Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
|ClinicalTrials.gov Identifier: NCT00330759|
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : April 9, 2014
Last Update Posted : July 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases||Biological: Denosumab Drug: Zoledronic Acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1779 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, 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.|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||October 2011|
U.S. FDA Resources
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
- Time to the First On-Study Skeletal-Related Event (Non-Inferiority) [ Time Frame: up to 33 months ]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 ]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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330759