Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
NCT ID: NCT03512262
Last Updated: 2023-04-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
228 participants
INTERVENTIONAL
2018-05-03
2021-09-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
NCT03710889
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
NCT01343004
Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis
NCT01657162
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
NCT00439647
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
NCT03841058
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Abaloparatide
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.
Abaloparatide
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
Placebo
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.
Placebo
Abaloparatide-matched placebo.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abaloparatide
Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway.
Placebo
Abaloparatide-matched placebo.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
85 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Radius Health, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States
Alta California Medical Group
Simi Valley, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Panorama Orthopedics & Spine Center
Golden, Colorado, United States
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
Washington D.C., District of Columbia, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
Baptist Diabetes Associates, Pa
Miami, Florida, United States
Center For Advanced Research & Education
Gainesville, Georgia, United States
Meridian Clinical Research
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States
SUNY Upstate Medical University
Syracuse, New York, United States
PMG Research of Cary, LLC
Cary, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Centex Studies, Inc.
Houston, Texas, United States
Centex Studies, Inc
McAllen, Texas, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
University of Wisconsin Osteoporosis Clinical Research Program
Madison, Wisconsin, United States
Azienda ospedaliera universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, Tuscany, Italy
Azienda ospedaliera universitaria integrata di verona(AOUI)
Verona, , Italy
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, Masovian Voivodeship, Poland
Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik
Bialystok, Podlaskie Voivodeship, Poland
ClinicMed Daniluk, Nowak Sp.j.
Bialystok, , Poland
Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
Lodz, , Poland
ETG Siedlce
Siedlce, , Poland
Lubelskie Centrum Diagnostyczne
Świdnik, , Poland
NZOZ Nasz Lekarz
Torun, , Poland
Synexus Polska Sp z o.o Oddzial we Wroclawiu
Wroclaw, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ATOM
Identifier Type: OTHER
Identifier Source: secondary_id
BA058-05-019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.