Trials / Completed
CompletedNCT00321620
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,904 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zoledronic acid | Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC |
| BIOLOGICAL | denosumab | Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2009-10-01
- Completion
- 2012-02-24
- First posted
- 2006-05-04
- Last updated
- 2018-08-29
- Results posted
- 2014-03-21
Source: ClinicalTrials.gov record NCT00321620. Inclusion in this directory is not an endorsement.