Trials / Completed
CompletedNCT00936897
A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 833 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ibandronate | Ibandronate 150mg PO QM (tablet) |
| DRUG | Denosumab | denosumab 60mg SC Q6M (pre-filled syringe) |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2011-11-01
- Completion
- 2012-01-01
- First posted
- 2009-07-10
- Last updated
- 2013-02-11
- Results posted
- 2012-11-29
Source: ClinicalTrials.gov record NCT00936897. Inclusion in this directory is not an endorsement.