drugset / Trial / NCT01457950
A Study in Korean 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 Korean postmenopausal women with osteoporosis.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-12
- Completion
- 2013-06
Outcome
Met primary endpoint
registry analysis (superiority or other test); Denosumab 60 mg vs Placebo; p <0.0001; Mean Difference (Final Values) 3.21 (95% CI 2.06 to 4.36); ANCOVA NCT01457950 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |