Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
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
2 other identifiers
interventional
228
3 countries
34
Brief Summary
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2018
Typical duration for phase_3
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2018
CompletedFirst Posted
Study publicly available on registry
April 30, 2018
CompletedStudy Start
First participant enrolled
May 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2021
CompletedResults Posted
Study results publicly available
April 7, 2023
CompletedApril 7, 2023
April 1, 2023
3.3 years
April 17, 2018
November 14, 2022
April 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Month 12
Secondary Outcomes (14)
Percent Change From Baseline in Total Hip BMD at Month 12
Baseline, Month 12
Percent Change From Baseline in Femoral Neck BMD at Month 12
Baseline, Month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 6
Baseline, Month 6
Percent Change in Total Hip BMD From Baseline at Month 6
Baseline, Month 6
Percent Change From Baseline in Femoral Neck BMD at Month 6
Baseline, Month 6
- +9 more secondary outcomes
Study Arms (2)
Abaloparatide
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, 94904, United States
Alta California Medical Group
Simi Valley, California, 93065, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Panorama Orthopedics & Spine Center
Golden, Colorado, 80401, United States
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
Washington D.C., District of Columbia, 20007, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012, United States
Baptist Diabetes Associates, Pa
Miami, Florida, 33156, United States
Center For Advanced Research & Education
Gainesville, Georgia, 30501, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Northwestern University
Chicago, Illinois, 60611, United States
The University of Chicago
Chicago, Illinois, 60637, United States
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
PMG Research of Cary, LLC
Cary, North Carolina, 27518, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
Centex Studies, Inc
McAllen, Texas, 78504, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
University of Wisconsin Osteoporosis Clinical Research Program
Madison, Wisconsin, 53705, United States
Azienda ospedaliera universitaria Careggi
Florence, Tuscany, 50139, Italy
Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, Tuscany, 53100, Italy
Azienda ospedaliera universitaria integrata di verona(AOUI)
Verona, 37134, Italy
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, 01-192, Poland
Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351, Poland
ClinicMed Daniluk, Nowak Sp.j.
Bialystok, 15-879, Poland
Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
Lodz, 90-558, Poland
ETG Siedlce
Siedlce, 08-110, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, 21-040, Poland
NZOZ Nasz Lekarz
Torun, 87100, Poland
Synexus Polska Sp z o.o Oddzial we Wroclawiu
Wroclaw, 50-381, Poland
Related Publications (3)
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.
PMID: 11241160BACKGROUNDMannstadt 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.
PMID: 10564229BACKGROUNDDempster 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.
PMID: 8119233BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations
- Organization
- Radius Health, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2018
First Posted
April 30, 2018
Study Start
May 3, 2018
Primary Completion
August 17, 2021
Study Completion
September 8, 2021
Last Updated
April 7, 2023
Results First Posted
April 7, 2023
Record last verified: 2023-04