At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,904 enrolled
Drug / intervention
zoledronic acid +1 moredrug
Likely dose
zoledronic acid 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating zoledronic acid and denosumab for Bone Metastases. Completed, enrolled 1,904 participants.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Metastases
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedMay 2006
Primary CompletionOct 2009
Study CompletionFeb 2012
TodayJul 2026
First PostedMay 4, 2006
Enrollment StartApr 1, 2006
Primary CompletionOct 1, 2009
Study CompletionFeb 24, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.2 years ago
Interventions
zoledronic aciddrug
Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
denosumabbiological
Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes