At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,779 enrolled
Drug / intervention
Denosumab +1 morebiological
Likely dose
Denosumab 120 milligramsfrom 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 Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma.
In Brief
A Phase 3 clinical trial evaluating Denosumab and Zoledronic Acid for Bone Metastases. Completed, enrolled 1,779 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 (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Metastases
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2006
Enrollment StartJun 2006
Primary CompletionApr 2009
Study CompletionOct 2011
TodayJul 2026
First PostedMay 29, 2006
Enrollment StartJun 1, 2006
Primary CompletionApr 1, 2009
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.1 years ago
Interventions
Denosumabbiological
120 milligrams by subcutaneous injection every 4 weeks
Zoledronic Aciddrug
4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks