Trials / Completed
CompletedNCT00043186
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
A Randomized, Double-Blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 412 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 80 Years
- Healthy volunteers
- Not accepted
Summary
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo subcutaneous injection |
| DRUG | Denosumab | Denosumab for subcutaneous injection |
| DRUG | Alendronate | Alendronate 70 mg tablets |
Timeline
- Start date
- 2002-05-01
- Primary completion
- 2007-04-01
- Completion
- 2007-06-01
- First posted
- 2002-08-07
- Last updated
- 2013-09-18
- Results posted
- 2010-07-28
Source: ClinicalTrials.gov record NCT00043186. Inclusion in this directory is not an endorsement.