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Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

Primary Purpose

Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abaloparatide
Placebo
Sponsored by
Radius Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring BA058, abaloparatide, abaloparatide-SC, osteoporosis, male osteoporosis, TYMLOS®, fracture, bone loss

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

INCLUSION CRITERIA

  • Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism.
  • The patient has a BMD T-score (based on the female reference range as assessed by the central imaging vendor) of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by DXA or ≤-1.5 and with radiologic evidence of vertebral fracture or a documented history of low-trauma nonvertebral fracture sustained in the past 5 years. Men older than 65 years may be enrolled if they have a BMD T-score ≤ -2.0 even if they do not meet the fracture criteria.
  • Normal medical history, physical examination, including vital signs, and body mass index (BMI).
  • Hypogonadal patients whose doses of androgens have been stable for at least twelve months before randomization are eligible and may continue therapy during the study.
  • Laboratory tests within the normal range including serum calcium (albumin-corrected), PTH, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone (TSH) values.

EXCLUSION CRITERIA

  • Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within L1-L4.
  • A BMD T-score of ≤-3.5 at the total hip, femoral neck, or lumbar spine based upon the female reference range.
  • Unevaluable hip BMD or patients who have undergone bilateral hip replacement.
  • Fragility fracture within the prior twelve months.
  • History of severe vertebral fracture or >2 moderate vertebral fractures.
  • History of bone disorders (e.g., Paget's disease) other than osteoporosis.
  • Patients with clinical signs of hypogonadism present at screening who plan to initiate testosterone replacement.
  • History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine.
  • History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the patient.
  • History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.

Sites / Locations

  • University of Alabama at Birmingham
  • Marin Endocrine Care & Research, Inc.
  • Alta California Medical Group
  • Diablo Clinical Research, Inc.
  • Panorama Orthopedics & Spine Center
  • MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
  • Indago Research & Health Center, Inc.
  • Baptist Diabetes Associates, Pa
  • Center For Advanced Research & Education
  • Meridian Clinical Research
  • Northwestern University
  • The University of Chicago
  • New Mexico Clinical Research & Osteoporosis Center, Inc.
  • SUNY Upstate Medical University
  • PMG Research of Cary, LLC
  • PMG Research of Wilmington, LLC
  • Ohio State University Medical Center
  • Altoona Center For Clinical Research
  • Centex Studies, Inc.
  • Centex Studies, Inc
  • Hunter Holmes McGuire VA Medical Center
  • University of Wisconsin Osteoporosis Clinical Research Program
  • Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
  • Azienda ospedaliera universitaria Careggi
  • Azienda ospedaliera universitaria integrata di verona(AOUI)
  • Krakowskie Centrum Medyczne Sp. z o.o.
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik
  • ClinicMed Daniluk, Nowak Sp.j.
  • ETG Siedlce
  • Lubelskie Centrum Diagnostyczne
  • NZOZ Nasz Lekarz
  • Synexus Polska Sp z o.o Oddzial we Wroclawiu
  • Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Abaloparatide

Placebo

Arm Description

Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Lumbar Spine BMD at Month 12
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.

Secondary Outcome Measures

Percent Change From Baseline in Total Hip BMD at Month 12
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Femoral Neck BMD at Month 12
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
Percent Change in Total Hip BMD From Baseline at Month 6
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Femoral Neck BMD at Month 6
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12
Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Distal One-third Radius BMD at Month 12
Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12
Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone.
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12
Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss).
Number of Participants With New Clinical Fractures
Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit).
Percent of Participants With Change in Disease Status
The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score ≤ -2.5. Osteopenia was defined as one of the following: Lumbar spine > -2.5 and total hip BMD T-score > -2.5 and < -1.0 Lumbar spine > -2.5 and < -1.0 and total hip BMD T-score > -2.5 Normal was defined as lumbar spine and total hip BMD T-score ≥ -1.0.
Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip
Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory.
Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12
QCT scans were evaluated by a central imaging laboratory.
Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12
QCT scans were evaluated by a central imaging laboratory.

Full Information

First Posted
April 17, 2018
Last Updated
April 6, 2023
Sponsor
Radius Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03512262
Brief Title
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
September 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radius Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
Detailed Description
The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide 80 micrograms (mcg) per day administered subcutaneously (SC) compared to placebo in men with osteoporosis. Efficacy was primarily assessed by the change in bone mineral density (BMD) over 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related Osteoporosis, Osteoporosis Senile, Osteoporosis of Vertebrae
Keywords
BA058, abaloparatide, abaloparatide-SC, osteoporosis, male osteoporosis, TYMLOS®, fracture, bone loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in a 2:1 treatment ratio (abaloparatide:placebo).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Treatment will be blinded to participants, investigators, outcome Assessor and care provider throughout the study except in a medical emergency where the identity of study medication is necessary to appropriately treat the participant.
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abaloparatide
Arm Type
Experimental
Arm Description
Participants self-administered daily doses of abaloparatide 80 mcg SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants self-administered daily doses of placebo SC using a single-participant, multiple-use, prefilled injection pen that delivers 30 doses. Participants received a new injection pen every 30 days.
Intervention Type
Drug
Intervention Name(s)
Abaloparatide
Other Intervention Name(s)
TYMLOS®, BA058, abaloparatide-SC
Intervention Description
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Abaloparatide-matched placebo.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Description
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Total Hip BMD at Month 12
Description
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Time Frame
Baseline, Month 12
Title
Percent Change From Baseline in Femoral Neck BMD at Month 12
Description
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Time Frame
Baseline, Month 12
Title
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Description
Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health.
Time Frame
Baseline, Month 6
Title
Percent Change in Total Hip BMD From Baseline at Month 6
Description
Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Time Frame
Baseline, Month 6
Title
Percent Change From Baseline in Femoral Neck BMD at Month 6
Description
Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health.
Time Frame
Baseline, Month 6
Title
Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12
Description
Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Time Frame
Baseline, Month 12
Title
Percent Change From Baseline in Distal One-third Radius BMD at Month 12
Description
Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health.
Time Frame
Baseline, Month 12
Title
Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12
Description
Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone.
Time Frame
Baseline, Month 12
Title
Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12
Description
Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss).
Time Frame
Baseline, Month 12
Title
Number of Participants With New Clinical Fractures
Description
Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit).
Time Frame
Baseline through Month 12
Title
Percent of Participants With Change in Disease Status
Description
The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score ≤ -2.5. Osteopenia was defined as one of the following: Lumbar spine > -2.5 and total hip BMD T-score > -2.5 and < -1.0 Lumbar spine > -2.5 and < -1.0 and total hip BMD T-score > -2.5 Normal was defined as lumbar spine and total hip BMD T-score ≥ -1.0.
Time Frame
Baseline through Month 12
Title
Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip
Description
Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory.
Time Frame
Month 12
Title
Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12
Description
QCT scans were evaluated by a central imaging laboratory.
Time Frame
Baseline, Month 12
Title
Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12
Description
QCT scans were evaluated by a central imaging laboratory.
Time Frame
Baseline, Month 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism. The participant has a BMD T-score based on female or male reference range (depending on date of enrollment) as assessed by the central imaging vendor of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA) or ≤ -1.5 and with radiologic evidence of vertebral fracture or a documented history of low-trauma nonvertebral fracture sustained in the past 5 years. Men older than 65 years may be enrolled if they have a BMD T-score ≤ -2.0 even if they do not meet the fracture criteria. Normal medical history, physical examination, including vital signs, and body mass index. Hypogonadal participants whose doses of androgens have been stable for at least twelve months before randomization are eligible and may continue therapy during the study. Laboratory tests within the normal range including serum calcium (albumin-corrected), parathyroid hormone, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone values. Key Exclusion Criteria Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal BMD, defined as having at least 2 radiologically evaluable vertebrae within L1-L4. A BMD T-score of ≤-3.5 at the total hip, femoral neck, or lumbar spine based on female or male reference range (depending on date of enrollment). Unevaluable hip BMD or participants who have undergone bilateral hip replacement. Fragility fracture within the prior twelve months. History of severe vertebral fracture or >2 moderate vertebral fractures. History of bone disorders (for example, Paget's disease) other than osteoporosis. participant with clinical signs of hypogonadism present at screening who plan to initiate testosterone replacement. History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine. History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the participant. History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Marin Endocrine Care & Research, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Alta California Medical Group
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Panorama Orthopedics & Spine Center
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Indago Research & Health Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Baptist Diabetes Associates, Pa
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Center For Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
PMG Research of Cary, LLC
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Centex Studies, Inc
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
University of Wisconsin Osteoporosis Clinical Research Program
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda ospedaliera universitaria Careggi
City
Florence
State/Province
Tuscany
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda ospedaliera universitaria integrata di verona(AOUI)
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Krakowskie Centrum Medyczne Sp. z o.o.
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
ClinicMed Daniluk, Nowak Sp.j.
City
Białystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
ETG Siedlce
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
NZOZ Nasz Lekarz
City
Toruń
ZIP/Postal Code
87100
Country
Poland
Facility Name
Synexus Polska Sp z o.o Oddzial we Wroclawiu
City
Wrocław
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
City
Łódź
ZIP/Postal Code
90-558
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
11241160
Citation
Rizzoli R, Bonjour JP, Ferrari SL. Osteoporosis, genetics and hormones. J Mol Endocrinol. 2001 Apr;26(2):79-94. doi: 10.1677/jme.0.0260079.
Results Reference
background
PubMed Identifier
10564229
Citation
Mannstadt M, Juppner H, Gardella TJ. Receptors for PTH and PTHrP: their biological importance and functional properties. Am J Physiol. 1999 Nov;277(5):F665-75. doi: 10.1152/ajprenal.1999.277.5.F665.
Results Reference
background
PubMed Identifier
8119233
Citation
Dempster DW, Cosman F, Parisien M, Shen V, Lindsay R. Anabolic actions of parathyroid hormone on bone. Endocr Rev. 1993 Dec;14(6):690-709. doi: 10.1210/edrv-14-6-690. No abstract available. Erratum In: Endocr Rev 1994 Apr;15(2):261.
Results Reference
background

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Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

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