Trials / Completed
CompletedNCT00091832
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer
A Randomized Active-controlled Study of AMG 162 in Breast Cancer Subjects With Bone Metastasis Who Have Not Previously Been Treated With Bisphosphonate Therapy.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 255 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Denosumab | Denosumab administered by subcutaneous injection |
| DRUG | IV Bisphosphonates | Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid |
Timeline
- Start date
- 2004-09-01
- Primary completion
- 2005-11-01
- Completion
- 2006-10-01
- First posted
- 2004-09-21
- Last updated
- 2014-01-28
- Results posted
- 2011-01-07
Source: ClinicalTrials.gov record NCT00091832. Inclusion in this directory is not an endorsement.