At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,049 enrolled
Drug / intervention
Denosumab +1 morebiological
Likely dose
Denosumab 120 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 Subjects With Advanced Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Denosumab and Zoledronic Acid for Bone Metastases. Completed, enrolled 2,049 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Metastases
Countries--
CollaboratorsDaiichi Sankyo
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2006
First PostedMay 2006
Primary CompletionJul 2009
Study CompletionApr 2012
TodayJul 2026
First PostedMay 3, 2006
Enrollment StartApr 1, 2006
Primary CompletionJul 20, 2009
Study CompletionApr 4, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.2 years ago
Interventions
Denosumabbiological
Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes
Zoledronic Aciddrug
Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC