Trials / Completed
CompletedNCT01457950
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
A Six Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study With a Six Month Open-Label Extension to Evaluate the Efficacy and Safety of Denosumab in Korean Postmenopausal Women With Osteoporosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 135 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 60 Years – 90 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 Korean postmenopausal women with osteoporosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | denosumab | double-blind phase: 60mg subcutaneous injection, single dose |
| DRUG | placebo | double-blind phase: placebo subcutaneous injection, single dose |
| DRUG | open-label denosumab | open-label phase: 60mg subcutaneous injection, single dose |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2012-12-01
- Completion
- 2013-06-01
- First posted
- 2011-10-24
- Last updated
- 2014-05-07
- Results posted
- 2013-10-29
Locations
10 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01457950. Inclusion in this directory is not an endorsement.