<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01674621</url>
  </required_header>
  <id_info>
    <org_study_id>BA058-05-007</org_study_id>
    <secondary_id>2012-001921-29</secondary_id>
    <nct_id>NCT01674621</nct_id>
  </id_info>
  <brief_title>Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 Administered Via a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women With Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radius Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nordic Bioscience A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Radius Health, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise&#xD;
      healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density&#xD;
      (BMD) and serum markers of bone metabolism when compared to transdermal placebo and&#xD;
      abaloparatide injection for 6 months of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2012</start_date>
  <completion_date type="Actual">August 2, 2013</completion_date>
  <primary_completion_date type="Actual">August 2, 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Since the abaloparatide injection arm was administered subcutaneously (SC), it was not possible to blind this arm of the study. Therefore, abaloparatide-SC was considered a reference drug, but the centralized BMD assessments and bone marker evaluations remained blinded to all treatment assignments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months</measure>
    <time_frame>Baseline, 6 Months</time_frame>
    <description>Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in BMD of Total Hip at 6 Months</measure>
    <time_frame>Baseline, 6 Months</time_frame>
    <description>Percent change in BMD as specified by DXA scans of the total hip.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in BMD of Forearm at 6 Months</measure>
    <time_frame>Baseline, 6 Months</time_frame>
    <description>Percent change in BMD as specified by DXA scans of the forearm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months</measure>
    <time_frame>Baseline, 6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months</measure>
    <time_frame>Baseline, 6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Serum Osteocalcin at 6 Months</measure>
    <time_frame>Baseline, 6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months</measure>
    <time_frame>Baseline, 6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months</measure>
    <time_frame>Baseline, 6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)</measure>
    <time_frame>Baseline up to 6 Months</time_frame>
    <description>A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes</measure>
    <time_frame>Baseline up to 7 Months</time_frame>
    <description>Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result</measure>
    <time_frame>Baseline up to 7 Months</time_frame>
    <description>The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4</measure>
    <time_frame>Baseline up to 6 Months</time_frame>
    <description>Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 &lt;1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: &lt;25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: &lt;65.0 g/L or &lt;4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: &lt;0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: &lt;0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, &gt; 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4</measure>
    <time_frame>Baseline up to 6 Months</time_frame>
    <description>Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), &gt;1.0 g%, or &gt;10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: &gt;6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: &gt;20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: &gt;20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: &gt;20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: &gt;3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4</measure>
    <time_frame>Baseline up to 6 Months</time_frame>
    <description>Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: &gt;2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: &gt;3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Post Menopausal Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Abaloparatide Transdermal (50 mcg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abaloparatide Transdermal (100 mcg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abaloparatide Transdermal (150 mcg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abaloparatide Injection (80 mcg)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abaloparatide Transdermal Placebo (0 mcg)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abaloparatide Transdermal (50 mcg)</intervention_name>
    <description>Abaloparatide Transdermal Microneedle Active Patch</description>
    <arm_group_label>Abaloparatide Transdermal (50 mcg)</arm_group_label>
    <other_name>BA058 Transdermal (50 mcg)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abaloparatide Transdermal (100 mcg)</intervention_name>
    <description>Abaloparatide Transdermal Microneedle Active Patch</description>
    <arm_group_label>Abaloparatide Transdermal (100 mcg)</arm_group_label>
    <other_name>BA058 Transdermal (100 mcg)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abaloparatide Transdermal (150 mcg)</intervention_name>
    <description>Abaloparatide Transdermal Microneedle Active Patch</description>
    <arm_group_label>Abaloparatide Transdermal (150 mcg)</arm_group_label>
    <other_name>BA058 Transdermal (150 mcg)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abaloparatide Injection (80 mcg)</intervention_name>
    <description>Abaloparatide Subcutaneous Injection</description>
    <arm_group_label>Abaloparatide Injection (80 mcg)</arm_group_label>
    <other_name>BA058 Injection (80 mcg)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abaloparatide Placebo</intervention_name>
    <description>Abaloparatide Transdermal Microneedle Placebo Patch</description>
    <arm_group_label>Abaloparatide Transdermal Placebo (0 mcg)</arm_group_label>
    <other_name>BA058 Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal woman, less than 85 years old.&#xD;
&#xD;
          -  BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture&#xD;
             (within 5 years).&#xD;
&#xD;
          -  Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.&#xD;
&#xD;
          -  Laboratory tests within the normal range, including serum calcium, Vitamin D,&#xD;
             parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMD T-score ≤-5.0 at the lumbar spine or hip.&#xD;
&#xD;
          -  History of bone disorders (for example, Paget's disease) other than postmenopausal&#xD;
             osteoporosis.&#xD;
&#xD;
          -  Significantly impaired renal function.&#xD;
&#xD;
          -  History of any cancer.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ballerup</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vejle</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Hong Kong</country>
  </removed_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <results_first_submitted>October 25, 2016</results_first_submitted>
  <results_first_submitted_qc>October 25, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 19, 2016</results_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BA058</keyword>
  <keyword>Abaloparatide-SC</keyword>
  <keyword>abaloparatide</keyword>
  <keyword>Abaloparatide-TD</keyword>
  <keyword>Osteo</keyword>
  <keyword>Osteoporosis</keyword>
  <keyword>Transdermal</keyword>
  <keyword>Patch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Osteoporosis, Postmenopausal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abaloparatide</mesh_term>
    <mesh_term>Parathyroid Hormone-Related Protein</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Abaloparatide Transdermal (50 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months</description>
        </group>
        <group group_id="P2">
          <title>Abaloparatide Transdermal (100 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
        </group>
        <group group_id="P3">
          <title>Abaloparatide Transdermal (150 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
        </group>
        <group group_id="P4">
          <title>Abaloparatide Injection (80 mcg)</title>
          <description>Abaloparatide-Subcutaneous (SC) Injection - 80 mcg daily injections for up to 6 months</description>
        </group>
        <group group_id="P5">
          <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="48"/>
                <participants group_id="P4" count="51"/>
                <participants group_id="P5" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Modified Intent-to-Treat Population</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="43"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="51"/>
                <participants group_id="P3" count="47"/>
                <participants group_id="P4" count="51"/>
                <participants group_id="P5" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="41"/>
                <participants group_id="P4" count="45"/>
                <participants group_id="P5" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inability to Complete Study Procedures</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Severe Abaloparatide-SC Hypersensitivity</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified Intent-to-Treat (mITT) population included randomized participants with pretreatment and end-of-treatment evaluable radiologic assessments.</population>
      <group_list>
        <group group_id="B1">
          <title>Abaloparatide Transdermal (50 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
        </group>
        <group group_id="B2">
          <title>Abaloparatide Transdermal (100 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
        </group>
        <group group_id="B3">
          <title>Abaloparatide Transdermal (150 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
        </group>
        <group group_id="B4">
          <title>Abaloparatide Injection (80 mcg)</title>
          <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
        </group>
        <group group_id="B5">
          <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="47"/>
            <count group_id="B2" value="46"/>
            <count group_id="B3" value="43"/>
            <count group_id="B4" value="49"/>
            <count group_id="B5" value="46"/>
            <count group_id="B6" value="231"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.9" spread="4.83"/>
                    <measurement group_id="B2" value="65.7" spread="5.26"/>
                    <measurement group_id="B3" value="66.3" spread="6.46"/>
                    <measurement group_id="B4" value="66.4" spread="5.48"/>
                    <measurement group_id="B5" value="66.5" spread="7.27"/>
                    <measurement group_id="B6" value="66.2" spread="5.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="49"/>
                    <measurement group_id="B5" value="46"/>
                    <measurement group_id="B6" value="231"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months</title>
        <description>Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.</description>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months</title>
          <description>Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.</description>
          <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.87" spread="2.87"/>
                    <measurement group_id="O2" value="2.33" spread="2.96"/>
                    <measurement group_id="O3" value="2.95" spread="3.13"/>
                    <measurement group_id="O4" value="5.80" spread="4.21"/>
                    <measurement group_id="O5" value="0.04" spread="2.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0066</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0005</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.930</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.555</ci_lower_limit>
            <ci_upper_limit>-2.305</ci_upper_limit>
            <estimate_desc>Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.470</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.104</ci_lower_limit>
            <ci_upper_limit>-1.837</ci_upper_limit>
            <estimate_desc>Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.856</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.519</ci_lower_limit>
            <ci_upper_limit>-1.193</ci_upper_limit>
            <estimate_desc>Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in BMD of Total Hip at 6 Months</title>
        <description>Percent change in BMD as specified by DXA scans of the total hip.</description>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>mITT population included all participants with pre-treatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in BMD of Total Hip at 6 Months</title>
          <description>Percent change in BMD as specified by DXA scans of the total hip.</description>
          <population>mITT population included all participants with pre-treatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="1.95"/>
                    <measurement group_id="O2" value="1.32" spread="1.96"/>
                    <measurement group_id="O3" value="1.49" spread="1.73"/>
                    <measurement group_id="O4" value="2.74" spread="3.05"/>
                    <measurement group_id="O5" value="-0.02" spread="2.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0547</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0056</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0018</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.768</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.864</ci_lower_limit>
            <ci_upper_limit>-0.672</ci_upper_limit>
            <estimate_desc>Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.420</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.522</ci_lower_limit>
            <ci_upper_limit>-0.318</ci_upper_limit>
            <estimate_desc>Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.247</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.368</ci_lower_limit>
            <ci_upper_limit>-0.126</ci_upper_limit>
            <estimate_desc>Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in BMD of Forearm at 6 Months</title>
        <description>Percent change in BMD as specified by DXA scans of the forearm.</description>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in BMD of Forearm at 6 Months</title>
          <description>Percent change in BMD as specified by DXA scans of the forearm.</description>
          <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="2.74"/>
                    <measurement group_id="O2" value="-0.16" spread="3.71"/>
                    <measurement group_id="O3" value="0.84" spread="2.96"/>
                    <measurement group_id="O4" value="0.33" spread="3.41"/>
                    <measurement group_id="O5" value="0.05" spread="3.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.9493</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.9806</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.5191</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.564</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.168</ci_lower_limit>
            <ci_upper_limit>1.040</ci_upper_limit>
            <estimate_desc>Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.483</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.115</ci_lower_limit>
            <ci_upper_limit>1.150</ci_upper_limit>
            <estimate_desc>Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.517</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.106</ci_lower_limit>
            <ci_upper_limit>2.139</ci_upper_limit>
            <estimate_desc>Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months</title>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months</title>
          <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.84" spread="23.87"/>
                    <measurement group_id="O2" value="5.22" spread="43.66"/>
                    <measurement group_id="O3" value="-5.52" spread="37.86"/>
                    <measurement group_id="O4" value="17.30" spread="42.76"/>
                    <measurement group_id="O5" value="10.23" spread="64.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.2549</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.9115</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.2390</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-22.146</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.501</ci_lower_limit>
            <ci_upper_limit>-3.790</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-12.086</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.543</ci_lower_limit>
            <ci_upper_limit>6.372</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-22.828</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.614</ci_lower_limit>
            <ci_upper_limit>-4.041</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months</title>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months</title>
          <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.26" spread="22.86"/>
                    <measurement group_id="O2" value="-8.42" spread="29.51"/>
                    <measurement group_id="O3" value="-16.63" spread="25.11"/>
                    <measurement group_id="O4" value="10.28" spread="72.31"/>
                    <measurement group_id="O5" value="-6.76" spread="31.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1632</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.9834</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.2179</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment (EOT) to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-27.541</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.557</ci_lower_limit>
            <ci_upper_limit>-6.525</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-18.702</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-39.835</ci_lower_limit>
            <ci_upper_limit>2.430</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-26.914</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.424</ci_lower_limit>
            <ci_upper_limit>-5.405</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Serum Osteocalcin at 6 Months</title>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum Osteocalcin at 6 Months</title>
          <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.37" spread="19.36"/>
                    <measurement group_id="O2" value="6.67" spread="33.38"/>
                    <measurement group_id="O3" value="-3.83" spread="22.01"/>
                    <measurement group_id="O4" value="69.54" spread="81.79"/>
                    <measurement group_id="O5" value="-4.21" spread="27.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>1.0000</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1200</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.9998</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-73.906</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-96.926</ci_lower_limit>
            <ci_upper_limit>-50.886</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-62.872</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-86.019</ci_lower_limit>
            <ci_upper_limit>-39.725</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-73.367</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-96.927</ci_lower_limit>
            <ci_upper_limit>-49.807</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months</title>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months</title>
          <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.76" spread="26.81"/>
                    <measurement group_id="O2" value="1.52" spread="57.29"/>
                    <measurement group_id="O3" value="-6.78" spread="38.91"/>
                    <measurement group_id="O4" value="97.64" spread="172.52"/>
                    <measurement group_id="O5" value="-7.26" spread="35.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.8569</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.6091</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.9999</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of PINP from baseline to EOT to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-110.398</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-156.966</ci_lower_limit>
            <ci_upper_limit>-63.831</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-96.115</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-142.940</ci_lower_limit>
            <ci_upper_limit>-49.290</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-104.418</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-152.079</ci_lower_limit>
            <ci_upper_limit>-56.758</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months</title>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months</title>
          <population>mITT population included all participants with pretreatment and end-of-treatment evaluable radiologic assessments. The participants were analyzed as randomized.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="46"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.61" spread="28.77"/>
                    <measurement group_id="O2" value="1.65" spread="48.66"/>
                    <measurement group_id="O3" value="-8.22" spread="54.84"/>
                    <measurement group_id="O4" value="41.11" spread="104.12"/>
                    <measurement group_id="O5" value="9.42" spread="22.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.3483</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.6839</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1067</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Dunnett's test</method>
            <method_desc>P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-43.721</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-75.748</ci_lower_limit>
            <ci_upper_limit>-11.694</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-39.461</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-71.665</ci_lower_limit>
            <ci_upper_limit>-7.257</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-49.334</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-82.113</ci_lower_limit>
            <ci_upper_limit>-16.555</ci_upper_limit>
            <estimate_desc>Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)</title>
        <description>A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.</description>
        <time_frame>Baseline up to 6 Months</time_frame>
        <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)</title>
          <description>A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.</description>
          <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>General appearance at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General appearance at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Head at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lungs at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lungs at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breasts at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdomen at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph nodes at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph nodes at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Columna at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Columna at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremities at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="23"/>
                    <measurement group_id="O5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extremities at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="25"/>
                    <measurement group_id="O5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurologic at Screening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurologic at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes</title>
        <description>Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
        <time_frame>Baseline up to 7 Months</time_frame>
        <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes</title>
          <description>Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
          <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Pressure Increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart Rate increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnoea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dizziness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result</title>
        <description>The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
        <time_frame>Baseline up to 7 Months</time_frame>
        <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result</title>
          <description>The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
          <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4</title>
        <description>Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 &lt;1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: &lt;25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: &lt;65.0 g/L or &lt;4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: &lt;0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: &lt;0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, &gt; 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
        <time_frame>Baseline up to 6 Months</time_frame>
        <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4</title>
          <description>Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 &lt;1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: &lt;25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: &lt;65.0 g/L or &lt;4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: &lt;0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: &lt;0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, &gt; 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
          <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4</title>
        <description>Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), &gt;1.0 g%, or &gt;10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: &gt;6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: &gt;20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: &gt;20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: &gt;20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: &gt;3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
        <time_frame>Baseline up to 6 Months</time_frame>
        <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4</title>
          <description>Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), &gt;1.0 g%, or &gt;10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: &gt;6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: &gt;20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: &gt;20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: &gt;20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: &gt;3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
          <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4</title>
        <description>Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: &gt;2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: &gt;3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
        <time_frame>Baseline up to 6 Months</time_frame>
        <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
        <group_list>
          <group group_id="O1">
            <title>Abaloparatide Transdermal (50 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O2">
            <title>Abaloparatide Transdermal (100 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O3">
            <title>Abaloparatide Transdermal (150 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
          </group>
          <group group_id="O4">
            <title>Abaloparatide Injection (80 mcg)</title>
            <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
          </group>
          <group group_id="O5">
            <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
            <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4</title>
          <description>Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: &gt;2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: &gt;3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.</description>
          <population>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="51"/>
                <count group_id="O3" value="47"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 7 Months</time_frame>
      <desc>Safety population included all participants who received 1 or more doses of study medication. The participants were analyzed as treated.</desc>
      <group_list>
        <group group_id="E1">
          <title>Abaloparatide Transdermal (50 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 50 mcg daily applications for up to 6 months</description>
        </group>
        <group group_id="E2">
          <title>Abaloparatide Transdermal (100 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months</description>
        </group>
        <group group_id="E3">
          <title>Abaloparatide Transdermal (150 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months</description>
        </group>
        <group group_id="E4">
          <title>Abaloparatide Injection (80 mcg)</title>
          <description>Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months</description>
        </group>
        <group group_id="E5">
          <title>Abaloparatide Transdermal Placebo (0 mcg)</title>
          <description>Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (15.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="37" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="41" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="39" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Application site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercalciuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="47"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Results may not be published prior to the Study Report completion. Investigators may publish results, providing a manuscript to the Sponsor =/&gt; 30 days prior to its submission to a publisher. Sponsor will provide manuscript to Investigators =/&gt; 30 days prior to its submission. Investigator shall comply with Sponsor's policy, withholding publication for an additional 60 days to permit the Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Program Director</name_or_title>
      <organization>Radius Health Inc.</organization>
      <phone>(617) 551-4700</phone>
      <email>info@radiuspharm.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01674621
org study id: BA058-05-007
secondary id: 2012-001921-29
nct id: NCT01674621
lead sponsor: 
collaborator: 
has dmc: No
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise
      healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density
      (BMD) and serum markers of bone metabolism when compared to transdermal placebo and
      abaloparatide injection for 6 months of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Since the abaloparatide injection arm was administered subcutaneously (SC), it was not possible to blind this arm of the study. Therefore, abaloparatide-SC was considered a reference drug, but the centralized BMD assessments and bone marker evaluations remained blinded to all treatment assignments.
measure: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
time frame: Baseline, 6 Months
description: Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
measure: Percent Change From Baseline in BMD of Total Hip at 6 Months
time frame: Baseline, 6 Months
description: Percent change in BMD as specified by DXA scans of the total hip.
measure: Percent Change From Baseline in BMD of Forearm at 6 Months
time frame: Baseline, 6 Months
description: Percent change in BMD as specified by DXA scans of the forearm.
measure: Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months
time frame: Baseline, 6 Months
measure: Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months
time frame: Baseline, 6 Months
measure: Percent Change From Baseline in Serum Osteocalcin at 6 Months
time frame: Baseline, 6 Months
measure: Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months
time frame: Baseline, 6 Months
measure: Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months
time frame: Baseline, 6 Months
measure: Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)
time frame: Baseline up to 6 Months
description: A full physical examination included, at a minimum: general appearance, skin, head/ears/eyes/nose/throat, lungs/chest, breasts, heart, abdomen, lymph nodes, musculoskeletal, extremities, and neurologic. Physical examination results that were considered abnormal were determined by the Investigator. A summary of other non-serious adverse events (AEs) and all serious AEs (SAEs), regardless of causality is located in Reported AE section.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes
time frame: Baseline up to 7 Months
description: Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of participants for each TEAE is presented. The same participant may be included in more than one TEAE category. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
measure: Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result
time frame: Baseline up to 7 Months
description: The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
measure: Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4
time frame: Baseline up to 6 Months
description: Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 <1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: <25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: <65.0 g/L or <4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, > 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
measure: Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
time frame: Baseline up to 6 Months
description: Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), >1.0 g%, or >10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: >6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: >20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: >3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
measure: Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4
time frame: Baseline up to 6 Months
description: Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: >2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: >3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
arm group label: Abaloparatide Transdermal (50 mcg)
arm group type: Experimental
description: Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
arm group label: Abaloparatide Transdermal (100 mcg)
arm group type: Experimental
description: Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
arm group label: Abaloparatide Transdermal (150 mcg)
arm group type: Experimental
description: Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
arm group label: Abaloparatide Injection (80 mcg)
arm group type: Active Comparator
description: Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
arm group label: Abaloparatide Transdermal Placebo (0 mcg)
arm group type: Placebo Comparator
description: Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
intervention type: Drug
intervention name: Abaloparatide Transdermal (50 mcg)
description: Abaloparatide Transdermal Microneedle Active Patch
arm group label: Abaloparatide Transdermal (50 mcg)
other name: BA058 Transdermal (50 mcg)
intervention type: Drug
intervention name: Abaloparatide Transdermal (100 mcg)
description: Abaloparatide Transdermal Microneedle Active Patch
arm group label: Abaloparatide Transdermal (100 mcg)
other name: BA058 Transdermal (100 mcg)
intervention type: Drug
intervention name: Abaloparatide Transdermal (150 mcg)
description: Abaloparatide Transdermal Microneedle Active Patch
arm group label: Abaloparatide Transdermal (150 mcg)
other name: BA058 Transdermal (150 mcg)
intervention type: Drug
intervention name: Abaloparatide Injection (80 mcg)
description: Abaloparatide Subcutaneous Injection
arm group label: Abaloparatide Injection (80 mcg)
other name: BA058 Injection (80 mcg)
intervention type: Drug
intervention name: Abaloparatide Placebo
description: Abaloparatide Transdermal Microneedle Placebo Patch
arm group label: Abaloparatide Transdermal Placebo (0 mcg)
other name: BA058 Placebo
criteria: 
gender: Female
minimum age: N/A
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Estonia
country: Poland
country: United States
country: Hong Kong
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
mesh term: Abaloparatide
mesh term: Parathyroid Hormone-Related Protein
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 