A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
This study has been completed.
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
First received: May 2, 2006
Last updated: March 25, 2014
Last verified: March 2014
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) [ Time Frame: Up to 34 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Time to First On-Study Skeletal-Related Event (Superiority) [ Time Frame: Up to 34 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2006|
|Study Completion Date:||April 2012|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
|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
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