<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/NCT01668589</url>
  </required_header>
  <id_info>
    <org_study_id>20110126</org_study_id>
    <nct_id>NCT01668589</nct_id>
  </id_info>
  <brief_title>Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis</brief_title>
  <official_title>Prospective Observational Study to Evaluate Medication-taking Behavior With Denosumab (Prolia) and Patient Characteristics in Postmenopausal Women With Osteoporosis in Routine Clinical Practice in Germany, Austria, Greece and Belgium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this observational study was to describe medication-taking behavior of&#xD;
      patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The decision to treat patients with denosumab was made independent of and before their&#xD;
      enrolment in the study. No study drug was administered as part of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2011</start_date>
  <completion_date type="Actual">August 31, 2015</completion_date>
  <primary_completion_date type="Actual">August 31, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months</measure>
    <time_frame>12 months and 24 months</time_frame>
    <description>A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart).&#xD;
A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months</measure>
    <time_frame>12 months and 24 months</time_frame>
    <description>A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).&#xD;
A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months</measure>
    <time_frame>From baseline to 12 months and 24 months</time_frame>
    <description>MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage.&#xD;
MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage.&#xD;
It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Non-persistence With Denosumab Injection</measure>
    <time_frame>24 months</time_frame>
    <description>Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Received Denosumab Injections Within the Specified Window</measure>
    <time_frame>24 months</time_frame>
    <description>The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months</measure>
    <time_frame>Baseline and Month 24</time_frame>
    <description>Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months</measure>
    <time_frame>Baseline and Month 24</time_frame>
    <description>Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months</measure>
    <time_frame>Baseline and Month 24</time_frame>
    <description>Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).</description>
  </secondary_outcome>
  <enrollment type="Actual">1501</enrollment>
  <condition>Postmenopausal Osteoporosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Postmenopausal women indicated for treatment of osteoporosis at increased risk of fractures&#xD;
        according to the approval regional prescribing information, e.g. EU SmPC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indicated for treatment of osteoporosis in postmenopausal women at increased risk of&#xD;
             fractures according to the approved Regional Prescribing Information (eg, EU SmPC in&#xD;
             Germany, Austria, Greece and Belgium).&#xD;
&#xD;
          -  Enrolled into the study within 4 weeks of receiving their first injection of Prolia®&#xD;
             according to the approved Regional Prescribing Information (eg, EU SmPC in Germany,&#xD;
             Austria, Greece and Belgium).&#xD;
&#xD;
          -  Appropriate written informed consent has been obtained (as required per local country&#xD;
             regulations).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is currently enrolled in or has been enrolled within the prior 6 months in a&#xD;
             study involving any investigational procedure, device or drug.&#xD;
&#xD;
          -  Contraindicated for treatment with Prolia® according to the approved Regional&#xD;
             Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium).&#xD;
&#xD;
          -  Participation in ongoing or previous denosumab clinical trials.&#xD;
&#xD;
          -  Patient has any kind of disorder that, in the opinion of the investigator, may&#xD;
             compromise the ability of the patient to give written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Graz</city>
        <zip>8010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Klagenfurt</city>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Landeck</city>
        <zip>6500</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leibnitz</city>
        <zip>8430</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lieboch</city>
        <zip>8501</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sankt Stefan</city>
        <zip>8511</zip>
        <country>Austria</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Voecklabruck</city>
        <zip>4840</zip>
        <country>Austria</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Voitsberg</city>
        <zip>8570</zip>
        <country>Austria</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wien</city>
        <zip>1040</zip>
        <country>Austria</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
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        <zip>1060</zip>
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  </location>
  <location>
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      <name>Research Site</name>
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  <location>
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  <location>
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        <city>Wien</city>
        <zip>1100</zip>
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  <location>
    <facility>
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  <location>
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  <location>
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      <address>
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      <address>
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      <address>
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      <name>Research Site</name>
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  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Thessaloniki</city>
        <zip>56429</zip>
        <country>Greece</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57001</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Greece</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <reference>
    <citation>Fahrleitner-Pammer A, Papaioannou N, Gielen E, Feudjo Tepie M, Toffis C, Frieling I, Geusens P, Makras P, Boschitsch E, Callens J, Anastasilakis AD, Niedhart C, Resch H, Kalouche-Khalil L, Hadji P. Factors associated with high 24-month persistence with denosumab: results of a real-world, non-interventional study of women with postmenopausal osteoporosis in Germany, Austria, Greece, and Belgium. Arch Osteoporos. 2017 Dec;12(1):58. doi: 10.1007/s11657-017-0351-2. Epub 2017 Jun 22.</citation>
    <PMID>28643265</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <results_first_submitted>August 1, 2016</results_first_submitted>
  <results_first_submitted_qc>August 1, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 20, 2016</results_first_posted>
  <last_update_submitted>January 5, 2018</last_update_submitted>
  <last_update_submitted_qc>January 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at various study centers in Germany, Austria, Greece, and Belgium. The recruitment period was from 28 November 2012 to 31 August 2013.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Germany</title>
          <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
        </group>
        <group group_id="P2">
          <title>Austria</title>
          <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
        </group>
        <group group_id="P3">
          <title>Greece</title>
          <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
        </group>
        <group group_id="P4">
          <title>Belgium</title>
          <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="600"/>
                <participants group_id="P2" count="300"/>
                <participants group_id="P3" count="300"/>
                <participants group_id="P4" count="301"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Denosumab</title>
              <participants_list>
                <participants group_id="P1" count="599"/>
                <participants group_id="P2" count="300"/>
                <participants group_id="P3" count="300"/>
                <participants group_id="P4" count="301"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="461"/>
                <participants group_id="P2" count="242"/>
                <participants group_id="P3" count="265"/>
                <participants group_id="P4" count="266"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="35"/>
                <participants group_id="P4" count="35"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Full Consent/Agreement Withdrawn</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS), defined as all enrolled patients with enrollment date into the electronic trial operations system, provided informed consent, and received 1 pre-enrollment denosumab injection.</population>
      <group_list>
        <group group_id="B1">
          <title>Germany</title>
          <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
        </group>
        <group group_id="B2">
          <title>Austria</title>
          <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
        </group>
        <group group_id="B3">
          <title>Greece</title>
          <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
        </group>
        <group group_id="B4">
          <title>Belgium</title>
          <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
        </group>
        <group group_id="B5">
          <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="579"/>
            <count group_id="B2" value="300"/>
            <count group_id="B3" value="299"/>
            <count group_id="B4" value="301"/>
            <count group_id="B5" value="1479"/>
          </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="72.5" spread="8.7"/>
                    <measurement group_id="B2" value="71.0" spread="9.5"/>
                    <measurement group_id="B3" value="66.3" spread="9.2"/>
                    <measurement group_id="B4" value="71.2" spread="10.4"/>
                    <measurement group_id="B5" value="70.7" spread="9.6"/>
                  </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="579"/>
                    <measurement group_id="B2" value="300"/>
                    <measurement group_id="B3" value="299"/>
                    <measurement group_id="B4" value="301"/>
                    <measurement group_id="B5" value="1479"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months</title>
        <description>A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart).&#xD;
A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart).</description>
        <time_frame>12 months and 24 months</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Germany</title>
            <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Austria</title>
            <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O3">
            <title>Greece</title>
            <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O4">
            <title>Belgium</title>
            <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months</title>
          <description>A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart).&#xD;
A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart).</description>
          <population>Full analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="579"/>
                <count group_id="O2" value="300"/>
                <count group_id="O3" value="299"/>
                <count group_id="O4" value="301"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.2" lower_limit="89.7" upper_limit="94.3"/>
                    <measurement group_id="O2" value="89.3" lower_limit="85.3" upper_limit="92.6"/>
                    <measurement group_id="O3" value="94.3" lower_limit="91.1" upper_limit="96.7"/>
                    <measurement group_id="O4" value="95.7" lower_limit="92.7" upper_limit="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.1" lower_limit="71.4" upper_limit="78.6"/>
                    <measurement group_id="O2" value="79.7" lower_limit="74.7" upper_limit="84.1"/>
                    <measurement group_id="O3" value="82.6" lower_limit="77.8" upper_limit="86.7"/>
                    <measurement group_id="O4" value="86.0" lower_limit="81.6" upper_limit="89.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months</title>
        <description>A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).&#xD;
A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).</description>
        <time_frame>12 months and 24 months</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Germany</title>
            <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Austria</title>
            <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O3">
            <title>Greece</title>
            <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O4">
            <title>Belgium</title>
            <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months</title>
          <description>A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).&#xD;
A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).</description>
          <population>Full analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="579"/>
                <count group_id="O2" value="300"/>
                <count group_id="O3" value="299"/>
                <count group_id="O4" value="301"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.6" lower_limit="84.6" upper_limit="90.1"/>
                    <measurement group_id="O2" value="85.0" lower_limit="80.4" upper_limit="88.8"/>
                    <measurement group_id="O3" value="89.6" lower_limit="85.6" upper_limit="92.8"/>
                    <measurement group_id="O4" value="89.0" lower_limit="84.9" upper_limit="92.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.9" lower_limit="58.8" upper_limit="66.8"/>
                    <measurement group_id="O2" value="66.0" lower_limit="60.3" upper_limit="71.3"/>
                    <measurement group_id="O3" value="69.6" lower_limit="64.0" upper_limit="74.7"/>
                    <measurement group_id="O4" value="70.1" lower_limit="64.6" upper_limit="75.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months</title>
        <description>MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage.&#xD;
MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage.&#xD;
It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%.</description>
        <time_frame>From baseline to 12 months and 24 months</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Germany</title>
            <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Austria</title>
            <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O3">
            <title>Greece</title>
            <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O4">
            <title>Belgium</title>
            <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months</title>
          <description>MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage.&#xD;
MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage.&#xD;
It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%.</description>
          <population>Full analysis set</population>
          <units>percentage of days of coverage</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="579"/>
                <count group_id="O2" value="300"/>
                <count group_id="O3" value="299"/>
                <count group_id="O4" value="301"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.5" lower_limit="93.5" upper_limit="95.5"/>
                    <measurement group_id="O2" value="93.2" lower_limit="91.6" upper_limit="94.9"/>
                    <measurement group_id="O3" value="95.8" lower_limit="94.6" upper_limit="96.9"/>
                    <measurement group_id="O4" value="96.2" lower_limit="95.1" upper_limit="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.4" lower_limit="85.8" upper_limit="89.1"/>
                    <measurement group_id="O2" value="87.9" lower_limit="85.3" upper_limit="90.4"/>
                    <measurement group_id="O3" value="91.2" lower_limit="89.3" upper_limit="93.1"/>
                    <measurement group_id="O4" value="92.4" lower_limit="90.5" upper_limit="94.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Non-persistence With Denosumab Injection</title>
        <description>Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.</description>
        <time_frame>24 months</time_frame>
        <population>Full analysis set who were non-persistent at 24 months</population>
        <group_list>
          <group group_id="O1">
            <title>Germany</title>
            <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Austria</title>
            <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O3">
            <title>Greece</title>
            <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O4">
            <title>Belgium</title>
            <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Non-persistence With Denosumab Injection</title>
          <description>Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.</description>
          <population>Full analysis set who were non-persistent at 24 months</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.23" lower_limit="6.03" upper_limit="17.89"/>
                    <measurement group_id="O2" value="6.03" lower_limit="6.03" upper_limit="13.05"/>
                    <measurement group_id="O3" value="12.00" lower_limit="6.03" upper_limit="13.38"/>
                    <measurement group_id="O4" value="12.20" lower_limit="6.03" upper_limit="17.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Received Denosumab Injections Within the Specified Window</title>
        <description>The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.</description>
        <time_frame>24 months</time_frame>
        <population>Full analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Germany</title>
            <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Austria</title>
            <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O3">
            <title>Greece</title>
            <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O4">
            <title>Belgium</title>
            <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Received Denosumab Injections Within the Specified Window</title>
          <description>The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.</description>
          <population>Full analysis set</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="579"/>
                <count group_id="O2" value="300"/>
                <count group_id="O3" value="299"/>
                <count group_id="O4" value="301"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No post-baseline injections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="0.9" lower_limit="6.03" upper_limit="17.89"/>
                    <measurement group_id="O2" value="9.7" spread="0.9" lower_limit="6.03" upper_limit="13.05"/>
                    <measurement group_id="O3" value="2.7" spread="0.7" lower_limit="6.03" upper_limit="13.38"/>
                    <measurement group_id="O4" value="3.7" spread="0.7" lower_limit="6.03" upper_limit="17.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 post-baseline injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8"/>
                    <measurement group_id="O2" value="3.7"/>
                    <measurement group_id="O3" value="7.0"/>
                    <measurement group_id="O4" value="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 post-baseline injections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2"/>
                    <measurement group_id="O2" value="7.0"/>
                    <measurement group_id="O3" value="7.7"/>
                    <measurement group_id="O4" value="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 post-baseline injections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.1"/>
                    <measurement group_id="O2" value="79.7"/>
                    <measurement group_id="O3" value="82.6"/>
                    <measurement group_id="O4" value="86.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months</title>
        <description>Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).</description>
        <time_frame>Baseline and Month 24</time_frame>
        <population>Full analysis set with a baseline value and a month 24 value measured with the same machine type.</population>
        <group_list>
          <group group_id="O1">
            <title>Germany</title>
            <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Austria</title>
            <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O3">
            <title>Greece</title>
            <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O4">
            <title>Belgium</title>
            <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months</title>
          <description>Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).</description>
          <population>Full analysis set with a baseline value and a month 24 value measured with the same machine type.</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="100"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="6.2"/>
                    <measurement group_id="O2" value="4.1" spread="3.2"/>
                    <measurement group_id="O3" value="6.6" spread="6.6"/>
                    <measurement group_id="O4" value="4.1" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months</title>
        <description>Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).</description>
        <time_frame>Baseline and Month 24</time_frame>
        <population>Full analysis set with a baseline value and a month 24 value measured with the same body side and machine type.</population>
        <group_list>
          <group group_id="O1">
            <title>Germany</title>
            <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Austria</title>
            <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O3">
            <title>Greece</title>
            <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O4">
            <title>Belgium</title>
            <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months</title>
          <description>Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).</description>
          <population>Full analysis set with a baseline value and a month 24 value measured with the same body side and machine type.</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="116"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="5.4"/>
                    <measurement group_id="O2" value="3.7" spread="5.7"/>
                    <measurement group_id="O3" value="6.0" spread="9.5"/>
                    <measurement group_id="O4" value="3.1" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months</title>
        <description>Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).</description>
        <time_frame>Baseline and Month 24</time_frame>
        <population>Full analysis set with a baseline value and a month 24 value measured with the same machine type.</population>
        <group_list>
          <group group_id="O1">
            <title>Germany</title>
            <description>Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O2">
            <title>Austria</title>
            <description>Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O3">
            <title>Greece</title>
            <description>Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
          <group group_id="O4">
            <title>Belgium</title>
            <description>Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months</title>
          <description>Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).</description>
          <population>Full analysis set with a baseline value and a month 24 value measured with the same machine type.</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="131"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="57"/>
                <count group_id="O4" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="6.2"/>
                    <measurement group_id="O2" value="8.2" spread="4.6"/>
                    <measurement group_id="O3" value="8.4" spread="8.3"/>
                    <measurement group_id="O4" value="7.8" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <desc>Only adverse drug reactions were collected in this observational study. Serious Adverse Events summarizes serious adverse drug reactions, defined as serious adverse events that are considered related to denosumab.&#xD;
Other Adverse Events summarizes the non-serious occurrences of adverse drug reactions that exceeded a 1% frequency threshold.</desc>
      <group_list>
        <group group_id="E1">
          <title>Germany</title>
          <description>Prolia 60 mg SC Q6M</description>
        </group>
        <group group_id="E2">
          <title>Austria</title>
          <description>Prolia 60 mg SC Q6M</description>
        </group>
        <group group_id="E3">
          <title>Greece</title>
          <description>Prolia 60 mg SC Q6M</description>
        </group>
        <group group_id="E4">
          <title>Belgium</title>
          <description>Prolia 60 mg SC Q6M</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</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="2" subjects_at_risk="579"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="301"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="579"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="301"/>
              </event>
              <event>
                <sub_title>Osteonecrosis of jaw</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="579"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="301"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="579"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="301"/>
              </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>The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
    </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/NCT01668589
org study id: 20110126
nct id: NCT01668589
lead sponsor: 
has dmc: No
The main objective of this observational study was to describe medication-taking behavior of
      patients treated with denosumab for postmenopausal osteoporosis (PMO) at 12 and 24 months.
The decision to treat patients with denosumab was made independent of and before their
      enrolment in the study. No study drug was administered as part of the study.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months
time frame: 12 months and 24 months
description: A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart).
A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart).
measure: Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months
time frame: 12 months and 24 months
description: A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).
A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).
measure: Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months
time frame: From baseline to 12 months and 24 months
description: MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage.
MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage.
It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%.
measure: Time to Non-persistence With Denosumab Injection
time frame: 24 months
description: Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.
measure: Percentage of Participants Who Received Denosumab Injections Within the Specified Window
time frame: 24 months
description: The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.
measure: Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months
time frame: Baseline and Month 24
description: Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).
measure: Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months
time frame: Baseline and Month 24
description: Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).
measure: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months
time frame: Baseline and Month 24
description: Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
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country: Austria
country: Belgium
country: Germany
country: Greece
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
citation: Fahrleitner-Pammer A, Papaioannou N, Gielen E, Feudjo Tepie M, Toffis C, Frieling I, Geusens P, Makras P, Boschitsch E, Callens J, Anastasilakis AD, Niedhart C, Resch H, Kalouche-Khalil L, Hadji P. Factors associated with high 24-month persistence with denosumab: results of a real-world, non-interventional study of women with postmenopausal osteoporosis in Germany, Austria, Greece, and Belgium. Arch Osteoporos. 2017 Dec;12(1):58. doi: 10.1007/s11657-017-0351-2. Epub 2017 Jun 22.
PMID: 28643265
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 