<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/NCT04467983</url>
  </required_header>
  <id_info>
    <org_study_id>ABLDEN</org_study_id>
    <nct_id>NCT04467983</nct_id>
  </id_info>
  <brief_title>Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone</brief_title>
  <official_title>Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Felicia Cosman, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Crozer-Keystone Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radius Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Osteoporosis Center of Delaware County</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized open label clinical trial will evaluate the effect of continued denosumab&#xD;
      alone over 18 months versus denosumab with added abaloparatide for 18 months. 70&#xD;
      postmenopausal women will be enrolled over a period of 18 months. The co-primary outcomes&#xD;
      will be group differences in bone mineral density (BMD) of the total hip and lumbar spine at&#xD;
      18 months. Secondary outcomes will include group differences in bone mineral density (BMD) at&#xD;
      the femoral neck, trochanter and wrist sites at 6, 12 and 18 months, spine and total hip bone&#xD;
      mineral density (BMD) at 6 and 12 months and trabecular bone score (TBS) at 18 months.&#xD;
      Secondary outcomes will also include within group changes from baseline for each of these&#xD;
      variables. Bone turnover markers will also be measured to demonstrate that PINP levels will&#xD;
      increase with administration of abaloparatide even in the setting of ongoing denosumab, while&#xD;
      CTX levels will remain low.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some women on denosumab treatment for osteoporosis remain at high risk for fracture. These&#xD;
      include women who sustain incident fractures on denosumab and those who have declining bone&#xD;
      mineral density (BMD) or persistently low bone mineral density (BMD), despite treatment.&#xD;
      There are few options available for these patients. Denosumab withdrawal is associated with&#xD;
      dramatic increased bone remodeling, rapid prominent bone loss, and multiple vertebral&#xD;
      fractures (Cummings JBMR 2017). Switching from denosumab to teriparatide is associated with&#xD;
      substantial BMD loss in the hip and femoral neck. After 2 years of denosumab treatment, when&#xD;
      women are switched to teriparatide, total hip BMD remains below the baseline (at end of&#xD;
      denosumab treatment) over the entire 2 years of teriparatide treatment (Leder Lancet 2015).&#xD;
&#xD;
      Abaloparatide might be a better option than teriparatide in patients switching from&#xD;
      denosumab, because it is less pro-resorptive than teriparatide, however, hip BMD will still&#xD;
      likely decline. Alternatively, adding abaloparatide to ongoing denosumab might be an&#xD;
      excellent treatment option for these women. One of the investigators has previously shown&#xD;
      that adding teriparatide to ongoing alendronate results in improved BMD and bone strength,&#xD;
      compared to switching to teriparatide (Cosman JCEM 2009 and Cosman JBMR 2013). Others have&#xD;
      shown that co-administration of teriparatide and denosumab to treatment naïve women increases&#xD;
      BMD more than either agent alone (Tsai Lancet 2013, Leder et al JCEM 2014). Based on both of&#xD;
      these observations, the investigators believe that adding abaloparatide to continued&#xD;
      denosumab treatment will allow bone formation to increase, without increasing bone resorption&#xD;
      (modeling-based bone formation) and will produce substantial BMD increments in both spine and&#xD;
      hip.&#xD;
&#xD;
      Hypothesis: In women who still appear to be at high risk for fracture while receiving ongoing&#xD;
      denosumab therapy, adding abaloparatide will increase BMD of the lumbar spine and total hip&#xD;
      significantly more than continuing denosumab alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone mineral density changes at total hip and lumbar spine</measure>
    <time_frame>18 months</time_frame>
    <description>Group differences in BMD increment at total hip and lumbar spine at 18 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone mineral density changes in increments</measure>
    <time_frame>6, 12, 18 months</time_frame>
    <description>Group Differences in BMD increments:&#xD;
of lumbar spine and total hip at 6 and 12 months. of femoral neck, and 1/3 radius at 6, 12 and 18 months.&#xD;
Group Differences in BMD increments:&#xD;
of lumbar spine and total hip at 6 and 12 months. of femoral neck, and 1/3 radius at 6, 12 and 18 months.&#xD;
Group Differences in BMD increments:&#xD;
of lumbar spine and total hip at 6 and 12 months. of femoral neck, and 1/3 radius at 6, 12 and 18 months. Group differences in BMD increments of lumbar spine and total hip (at 6 and 12 months) and of femoral neck and 1/3 distal radius (at 6, 12, and 18 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trabecular Bone Score changes</measure>
    <time_frame>18 months</time_frame>
    <description>Group differences in Trabecular Bone Score at 18 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within Group Increments in bone mineral density (vs baseline)</measure>
    <time_frame>6, 12, 18 months</time_frame>
    <description>Within Group Increments in bone mineral density vs baseline of lumbar spine (at 6, 12, and 18 months) and of total hip, femoral neck, and distal 1/3 radius (at 6, 12, and 18 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in biochemical bone turnover markers</measure>
    <time_frame>3, 6, 12, 18 months</time_frame>
    <description>Within and between group differences in biochemical bone turnover markers (P1NP and CTX) at 3, 6, 12, and 18 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Osteoporosis, Postmenopausal</condition>
  <arm_group>
    <arm_group_label>Denosumab alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Denosumab Injection</intervention_name>
    <description>Denosumab alone: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.</description>
    <arm_group_label>Combination therapy</arm_group_label>
    <arm_group_label>Denosumab alone</arm_group_label>
    <other_name>Prolia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abaloparatide</intervention_name>
    <description>Combination therapy: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.</description>
    <arm_group_label>Combination therapy</arm_group_label>
    <other_name>Tymlos</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  postmenopausal woman &gt;age 45 of any racial origin&#xD;
&#xD;
          -  Participants will have received at least 4 prior denosumab treatments and be within 7&#xD;
             months from their last denosumab injection&#xD;
&#xD;
          -  Participants are willing to participate for the duration of the study and have no&#xD;
             physical or psychological illness that would prohibit them from participating.&#xD;
&#xD;
          -  Diagnosis of osteoporosis based on bone mineral density and/or fracture criteria.&#xD;
             Osteoporosis will be defined by bone mineral density T-Score &lt; -2.5 at lumbar spine&#xD;
             (at least 2 evaluable vertebrae between L1 and L4), total hip or femoral neck.&#xD;
             Osteoporosis will also be defined clinically in women with osteoporotic fractures&#xD;
             within the preceding 5 years, including clinical vertebral or nonvertebral fractures&#xD;
             or vertebral fracture confirmed by radiograph or lateral DXA VFA image, along with a&#xD;
             DXA BMD T-Score &lt; -1.5 at one or more skeletal sites.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of drugs other than denosumab (within the preceding 3 months) known to affect&#xD;
             skeletal or calcium homeostasis.&#xD;
&#xD;
          -  Fewer than 2 evaluable lumbar vertebrae&#xD;
&#xD;
          -  A history of a symptomatic renal stone within the past 2 years or history of multiple&#xD;
             symptomatic renal stones within the preceding 10 years&#xD;
&#xD;
          -  Skeletal Disorders other than osteoporosis, including hypercalcemia,&#xD;
             hyperparathyroidism, or Paget's Disease&#xD;
&#xD;
          -  History of external or internal radiation therapy&#xD;
&#xD;
          -  Estimated GFR below 30 ml/min&#xD;
&#xD;
          -  Any contraindications to receipt of Abaloparatide or Denosumab&#xD;
&#xD;
          -  History of any cancer in past 5 years (except basal/squamous skin cancer)&#xD;
&#xD;
          -  Unexplained elevation of Serum Alkaline Phosphatase&#xD;
&#xD;
          -  History of atypical femoral fracture&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacqi Kernaghan, PA-C</last_name>
    <role>Study Director</role>
    <affiliation>Crozer-Keystone Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jacqi Kernaghan, PA-C</last_name>
    <phone>6109386701</phone>
    <email>jacqueline.kernaghan@crozer.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Barry Jacobson, MD</last_name>
    <phone>6109386701</phone>
    <email>barry.jacobson@crozer.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Osteoporosis Center of Delaware County</name>
      <address>
        <city>Broomall</city>
        <state>Pennsylvania</state>
        <zip>19008</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacqi Kernaghan, PA-C</last_name>
      <phone>610-938-6701</phone>
      <email>jacqueline.kernaghan@crozer.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Leder BZ, Tsai JN, Uihlein AV, Wallace PM, Lee H, Neer RM, Burnett-Bowie SA. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial. Lancet. 2015 Sep 19;386(9999):1147-55. doi: 10.1016/S0140-6736(15)61120-5. Epub 2015 Jul 2.</citation>
    <PMID>26144908</PMID>
  </reference>
  <reference>
    <citation>Cosman F, Wermers RA, Recknor C, Mauck KF, Xie L, Glass EV, Krege JH. Effects of teriparatide in postmenopausal women with osteoporosis on prior alendronate or raloxifene: differences between stopping and continuing the antiresorptive agent. J Clin Endocrinol Metab. 2009 Oct;94(10):3772-80. doi: 10.1210/jc.2008-2719. Epub 2009 Jul 7.</citation>
    <PMID>19584192</PMID>
  </reference>
  <reference>
    <citation>Cosman F, Keaveny TM, Kopperdahl D, Wermers RA, Wan X, Krohn KD, Krege JH. Hip and spine strength effects of adding versus switching to teriparatide in postmenopausal women with osteoporosis treated with prior alendronate or raloxifene. J Bone Miner Res. 2013 Jun;28(6):1328-36. doi: 10.1002/jbmr.1853.</citation>
    <PMID>23281041</PMID>
  </reference>
  <reference>
    <citation>Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015 Feb;100(2):697-706. doi: 10.1210/jc.2014-3718. Epub 2014 Nov 13.</citation>
    <PMID>25393645</PMID>
  </reference>
  <reference>
    <citation>Leder BZ, Tsai JN, Uihlein AV, Burnett-Bowie SA, Zhu Y, Foley K, Lee H, Neer RM. Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial. J Clin Endocrinol Metab. 2014 May;99(5):1694-700. doi: 10.1210/jc.2013-4440. Epub 2014 Feb 11.</citation>
    <PMID>24517156</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>February 12, 2021</last_update_submitted>
  <last_update_submitted_qc>February 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Osteoporosis Center of Delaware County</investigator_affiliation>
    <investigator_full_name>Felicia Cosman, MD</investigator_full_name>
    <investigator_title>Sub-Investigator</investigator_title>
  </responsible_party>
  <keyword>denosumab</keyword>
  <keyword>abaloparatide</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>Denosumab</mesh_term>
    <mesh_term>Abaloparatide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04467983
org study id: ABLDEN
nct id: NCT04467983
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This randomized open label clinical trial will evaluate the effect of continued denosumab
      alone over 18 months versus denosumab with added abaloparatide for 18 months. 70
      postmenopausal women will be enrolled over a period of 18 months. The co-primary outcomes
      will be group differences in bone mineral density (BMD) of the total hip and lumbar spine at
      18 months. Secondary outcomes will include group differences in bone mineral density (BMD) at
      the femoral neck, trochanter and wrist sites at 6, 12 and 18 months, spine and total hip bone
      mineral density (BMD) at 6 and 12 months and trabecular bone score (TBS) at 18 months.
      Secondary outcomes will also include within group changes from baseline for each of these
      variables. Bone turnover markers will also be measured to demonstrate that PINP levels will
      increase with administration of abaloparatide even in the setting of ongoing denosumab, while
      CTX levels will remain low.
Some women on denosumab treatment for osteoporosis remain at high risk for fracture. These
      include women who sustain incident fractures on denosumab and those who have declining bone
      mineral density (BMD) or persistently low bone mineral density (BMD), despite treatment.
      There are few options available for these patients. Denosumab withdrawal is associated with
      dramatic increased bone remodeling, rapid prominent bone loss, and multiple vertebral
      fractures (Cummings JBMR 2017). Switching from denosumab to teriparatide is associated with
      substantial BMD loss in the hip and femoral neck. After 2 years of denosumab treatment, when
      women are switched to teriparatide, total hip BMD remains below the baseline (at end of
      denosumab treatment) over the entire 2 years of teriparatide treatment (Leder Lancet 2015).

      Abaloparatide might be a better option than teriparatide in patients switching from
      denosumab, because it is less pro-resorptive than teriparatide, however, hip BMD will still
      likely decline. Alternatively, adding abaloparatide to ongoing denosumab might be an
      excellent treatment option for these women. One of the investigators has previously shown
      that adding teriparatide to ongoing alendronate results in improved BMD and bone strength,
      compared to switching to teriparatide (Cosman JCEM 2009 and Cosman JBMR 2013). Others have
      shown that co-administration of teriparatide and denosumab to treatment naïve women increases
      BMD more than either agent alone (Tsai Lancet 2013, Leder et al JCEM 2014). Based on both of
      these observations, the investigators believe that adding abaloparatide to continued
      denosumab treatment will allow bone formation to increase, without increasing bone resorption
      (modeling-based bone formation) and will produce substantial BMD increments in both spine and
      hip.

      Hypothesis: In women who still appear to be at high risk for fracture while receiving ongoing
      denosumab therapy, adding abaloparatide will increase BMD of the lumbar spine and total hip
      significantly more than continuing denosumab alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bone mineral density changes at total hip and lumbar spine
time frame: 18 months
description: Group differences in BMD increment at total hip and lumbar spine at 18 months.
measure: Bone mineral density changes in increments
time frame: 6, 12, 18 months
description: Group Differences in BMD increments:
of lumbar spine and total hip at 6 and 12 months. of femoral neck, and 1/3 radius at 6, 12 and 18 months.
Group Differences in BMD increments:
of lumbar spine and total hip at 6 and 12 months. of femoral neck, and 1/3 radius at 6, 12 and 18 months.
Group Differences in BMD increments:
of lumbar spine and total hip at 6 and 12 months. of femoral neck, and 1/3 radius at 6, 12 and 18 months. Group differences in BMD increments of lumbar spine and total hip (at 6 and 12 months) and of femoral neck and 1/3 distal radius (at 6, 12, and 18 months)
measure: Trabecular Bone Score changes
time frame: 18 months
description: Group differences in Trabecular Bone Score at 18 months
measure: Within Group Increments in bone mineral density (vs baseline)
time frame: 6, 12, 18 months
description: Within Group Increments in bone mineral density vs baseline of lumbar spine (at 6, 12, and 18 months) and of total hip, femoral neck, and distal 1/3 radius (at 6, 12, and 18 months)
measure: Differences in biochemical bone turnover markers
time frame: 3, 6, 12, 18 months
description: Within and between group differences in biochemical bone turnover markers (P1NP and CTX) at 3, 6, 12, and 18 months
arm group label: Denosumab alone
arm group type: Active Comparator
description: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.
arm group label: Combination therapy
arm group type: Active Comparator
description: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.
intervention type: Drug
intervention name: Denosumab Injection
description: Denosumab alone: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.
arm group label: Combination therapy
arm group label: Denosumab alone
other name: Prolia
intervention type: Drug
intervention name: Abaloparatide
description: Combination therapy: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.
arm group label: Combination therapy
other name: Tymlos
criteria: 
gender: Female
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jacqi Kernaghan, PA-C
role: Study Director
affiliation: Crozer-Keystone Health System
last name: Jacqi Kernaghan, PA-C
phone: 6109386701
email: jacqueline.kernaghan@crozer.org
last name: Barry Jacobson, MD
phone: 6109386701
email: barry.jacobson@crozer.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Leder BZ, Tsai JN, Uihlein AV, Wallace PM, Lee H, Neer RM, Burnett-Bowie SA. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial. Lancet. 2015 Sep 19;386(9999):1147-55. doi: 10.1016/S0140-6736(15)61120-5. Epub 2015 Jul 2.
PMID: 26144908
citation: Cosman F, Wermers RA, Recknor C, Mauck KF, Xie L, Glass EV, Krege JH. Effects of teriparatide in postmenopausal women with osteoporosis on prior alendronate or raloxifene: differences between stopping and continuing the antiresorptive agent. J Clin Endocrinol Metab. 2009 Oct;94(10):3772-80. doi: 10.1210/jc.2008-2719. Epub 2009 Jul 7.
PMID: 19584192
citation: Cosman F, Keaveny TM, Kopperdahl D, Wermers RA, Wan X, Krohn KD, Krege JH. Hip and spine strength effects of adding versus switching to teriparatide in postmenopausal women with osteoporosis treated with prior alendronate or raloxifene. J Bone Miner Res. 2013 Jun;28(6):1328-36. doi: 10.1002/jbmr.1853.
PMID: 23281041
citation: Leder BZ, O'Dea LS, Zanchetta JR, Kumar P, Banks K, McKay K, Lyttle CR, Hattersley G. Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2015 Feb;100(2):697-706. doi: 10.1210/jc.2014-3718. Epub 2014 Nov 13.
PMID: 25393645
citation: Leder BZ, Tsai JN, Uihlein AV, Burnett-Bowie SA, Zhu Y, Foley K, Lee H, Neer RM. Two years of Denosumab and teriparatide administration in postmenopausal women with osteoporosis (The DATA Extension Study): a randomized controlled trial. J Clin Endocrinol Metab. 2014 May;99(5):1694-700. doi: 10.1210/jc.2013-4440. Epub 2014 Feb 11.
PMID: 24517156
responsible party type: Sponsor-Investigator
investigator affiliation: Osteoporosis Center of Delaware County
investigator full name: Felicia Cosman, MD
investigator title: Sub-Investigator
mesh term: Osteoporosis
mesh term: Osteoporosis, Postmenopausal
mesh term: Denosumab
mesh term: Abaloparatide
sharing ipd: No