Trials / Completed
CompletedNCT00377819
Study of Transitioning From Alendronate to Denosumab
A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 504 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | alendronate | 70 mg oral QW |
| DRUG | Denosumab (AMG 162) | 60 mg SC q 6 mos |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2008-03-01
- Completion
- 2008-07-01
- First posted
- 2006-09-18
- Last updated
- 2011-07-11
- Results posted
- 2010-08-03
Source: ClinicalTrials.gov record NCT00377819. Inclusion in this directory is not an endorsement.