drugset / Trial / NCT01495000
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.
Timeline
- Start
- 2012-01
- Primary completion
- 2013-02
- Completion
- 2013-02
Outcome
Met primary endpoint
registry analysis (superiority or other test); Denosumab 60 mg vs Placebo; p <0.0001; Mean Difference (Final Values) 3.05 (95% CI 1.91 to 4.19); ANCOVA NCT01495000 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |