Preventing Osteoporosis Using Denosumab
Summary
The purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Timeline
- Start
- 2016-06
- Primary completion
- 2023-08
- Completion
- 2023-08
Outcome
Met primary endpoint
registry analysis (superiority test); Women Denosumab vs Women Placebo Group; p = .007; Mean Difference (Final Values) 4.80; Mixed Models Analysis NCT02753283 ↗
registry analysis (superiority test); Men Denosumab vs Men Placebo Group; p = .018; Mean Difference (Final Values) 2.70; Mixed Models Analysis NCT02753283 ↗
registry analysis (superiority test); Women Denosumab vs Women Placebo Group; p = .014; Mean Difference (Final Values) 3.99; Mixed Models Analysis NCT02753283 ↗
registry analysis (superiority test); Men Denosumab vs Men Placebo Group; p = .002; Mean Difference (Final Values) 5.16; Mixed Models Analysis NCT02753283 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |