Trials / Completed
CompletedNCT00321464
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Subjects With Advanced Breast Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,049 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Denosumab | Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes |
| DRUG | Zoledronic Acid | Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2009-07-20
- Completion
- 2012-04-04
- First posted
- 2006-05-03
- Last updated
- 2022-11-08
- Results posted
- 2014-03-10
Source: ClinicalTrials.gov record NCT00321464. Inclusion in this directory is not an endorsement.