Trials / Completed
CompletedNCT03512262
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 228 (actual)
- Sponsor
- Radius Health, Inc. · Industry
- Sex
- Male
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Osteoporosis
- Osteoporosis, Age-Related
- Osteoporosis Localized to Spine
- Age Related Osteoporosis
- Osteoporosis Senile
- Osteoporosis of Vertebrae
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abaloparatide | Abaloparatide is a synthetic peptide that is a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway. |
| DRUG | Placebo | Abaloparatide-matched placebo. |
Timeline
- Start date
- 2018-05-03
- Primary completion
- 2021-08-17
- Completion
- 2021-09-08
- First posted
- 2018-04-30
- Last updated
- 2023-04-07
- Results posted
- 2023-04-07
Locations
34 sites across 3 countries: United States, Italy, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03512262. Inclusion in this directory is not an endorsement.