A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
|ClinicalTrials.gov Identifier: NCT00321464|
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : March 10, 2014
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases||Biological: Denosumab Drug: Zoledronic Acid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2049 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, 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 Breast Cancer|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||April 2012|
|Active Comparator: zoledronic acid||
Drug: Zoledronic Acid
Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
Other Name: Zometa
Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes
- Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) [ Time Frame: Up to 34 months ]Time to first on-study skeletal-related event (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.
- Time to First On-Study Skeletal-Related Event (Superiority) [ Time Frame: Up to 34 months ]Time to first on-study skeletal-related event (SRE) using a superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.
- Time to First and Subsequent On-Study Skeletal-Related Event [ Time Frame: Up to 34 months ]Time to first and subsequent on-study skeletal-related event (SRE) using a 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 number of events.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321464