Trials / Completed
CompletedNCT01495000
A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
A Six-Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Denosumab in Indian Postmenopausal Women With Osteoporosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 55 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | denosumab | 60mg subcutaneous injection, single dose |
| DRUG | placebo | placebo subcutaneous injection, single dose |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2013-02-01
- Completion
- 2013-02-01
- First posted
- 2011-12-19
- Last updated
- 2014-02-07
- Results posted
- 2013-12-25
Locations
11 sites across 1 country: India
Source: ClinicalTrials.gov record NCT01495000. Inclusion in this directory is not an endorsement.