Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||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.|
- Time to the First On-Study Skeletal-Related Event (Non-Inferiority) [ Time Frame: up to 33 months ] [ Designated as safety issue: No ]Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.
- Time to First On-Study Skeletal-Related Event (Superiority) [ Time Frame: up to 33 months ] [ Designated as safety issue: No ]Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.
- Time to the First-and-Subsequent On-Study Skeletal-Related Event [ Time Frame: up to 33 months ] [ Designated as safety issue: No ]
Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE.
This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.
|Study Start Date:||June 2006|
|Study Completion Date:||October 2011|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Active Comparator: zoledronic acid
denosumab placebo with active zoledronic acid
Drug: Zoledronic Acid
4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks
Other Name: Zometa
active denosumab with zoledronic acid placebo
120 milligrams by subcutaneous injection every 4 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330759