Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
Study Details
Study Description
Brief Summary
A 12 month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide-SC 80 mcg per day compared to placebo as assessed by change in bone mineral density over 12 months.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Abaloparatide (BA058) Abaloparatide is an active synthetic peptide of parathyroid hormone |
Drug: Abaloparatide
Abaloparatide 80 mcg subcutaneous daily
Other Names:
|
Placebo Comparator: Placebo Placebo with no peptide of parathyroid hormone |
Drug: Placebo
Placebo 0 mcg subcutaneous daily
|
Outcome Measures
Primary Outcome Measures
- Lumbar spine bone mineral density (BMD) [12 months]
Percent change from baseline in lumbar spine BMD
Secondary Outcome Measures
- Total hip BMD [12 months]
Percent change from baseline for total hip BMD
- Femoral neck BMD [12 months]
Percent change from baseline for femoral neck BMD
- Lumbar spine BMD [6 months]
Percent change from baseline in lumbar spine BMD
- Treatment-emergent adverse events (TEAEs) associated with hypercalcemia [13 months]
Percent of participants reporting TEAE associated with hypercalcemia
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
2 | Marin Endocrine Care & Research, Inc. | Greenbrae | California | United States | 94904 |
3 | Alta California Medical Group | Simi Valley | California | United States | 93065 |
4 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
5 | Panorama Orthopedics & Spine Center | Golden | Colorado | United States | 80401 |
6 | MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) | Washington | District of Columbia | United States | 20007 |
7 | Indago Research & Health Center, Inc. | Hialeah | Florida | United States | 33012 |
8 | Baptist Diabetes Associates, Pa | Miami | Florida | United States | 33156 |
9 | Center For Advanced Research & Education | Gainesville | Georgia | United States | 30501 |
10 | Meridian Clinical Research | Savannah | Georgia | United States | 31406 |
11 | Northwestern University | Chicago | Illinois | United States | 60611 |
12 | The University of Chicago | Chicago | Illinois | United States | 60637 |
13 | New Mexico Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico | United States | 87106 |
14 | SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
15 | PMG Research of Cary, LLC | Cary | North Carolina | United States | 27518 |
16 | PMG Research of Wilmington, LLC | Wilmington | North Carolina | United States | 28401 |
17 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
18 | Altoona Center For Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
19 | Centex Studies, Inc. | Houston | Texas | United States | 77058 |
20 | Centex Studies, Inc | McAllen | Texas | United States | 78504 |
21 | Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | United States | 23249 |
22 | University of Wisconsin Osteoporosis Clinical Research Program | Madison | Wisconsin | United States | 53705 |
23 | Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte | Siena | Toscana | Italy | 53100 |
24 | Azienda ospedaliera universitaria Careggi | Florence | Tuscany | Italy | 50139 |
25 | Azienda ospedaliera universitaria integrata di verona(AOUI) | Verona | Italy | 37134 | |
26 | Krakowskie Centrum Medyczne Sp. z o.o. | Kraków | Malopolskie | Poland | 31-501 |
27 | Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warszawa | Mazowieckie | Poland | 01-192 |
28 | Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik | Białystok | Podlaskie | Poland | 15-351 |
29 | ClinicMed Daniluk, Nowak Sp.j. | Białystok | Poland | 15-879 | |
30 | ETG Siedlce | Siedlce | Poland | 08-110 | |
31 | Lubelskie Centrum Diagnostyczne | Swidnik | Poland | 21-040 | |
32 | NZOZ Nasz Lekarz | Toruń | Poland | 87100 | |
33 | Synexus Polska Sp z o.o Oddzial we Wroclawiu | Wrocław | Poland | 50-381 | |
34 | Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci | Łódź | Poland | 90-558 |
Sponsors and Collaborators
- Radius Health, Inc.
Investigators
- Study Director: Sr. Director, Clinical Operations, Radius Health, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review. Erratum in: Endocr Rev 1994 Apr;15(2):261.
- Mannstadt M, Jüppner 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. Review.
- Rizzoli R, Bonjour JP, Ferrari SL. Osteoporosis, genetics and hormones. J Mol Endocrinol. 2001 Apr;26(2):79-94. Review.
- BA058-05-019
- ATOM