A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
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|ClinicalTrials.gov Identifier: NCT00321464|
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : March 10, 2014
Last Update Posted : October 17, 2018
|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|
|Actual Study Start Date :||April 1, 2006|
|Actual Primary Completion Date :||July 20, 2009|
|Actual Study Completion Date :||April 4, 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.
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): NCT00321464