Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330759