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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):
Amgen Identifier:
First received: May 2, 2006
Last updated: January 25, 2017
Last verified: January 2017
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.

Condition Intervention Phase
Bone Metastases
Biological: Denosumab
Drug: Zoledronic Acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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 ]
    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 ]
    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.

Enrollment: 2049
Study Start Date: April 2006
Study Completion Date: April 2012
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: denosumab Biological: Denosumab
Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults with histologically or cytologically confirmed breast adenocarcinoma
  • radiographic evidence of at least one bone mets
  • Easter Cooperative Oncology Group status of 0, 1 or 2;
  • adequate organ function

Exclusion Criteria:

  • Current or prior IV bisphosphonate administration
  • current or prior oral bisphosphonates for bone mets
  • life expectancy of less than 6 months
  Contacts and Locations
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Please refer to this study by its identifier: NCT00321464

Sponsors and Collaborators
Daiichi Sankyo Inc.
Study Director: MD Amgen
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Amgen Identifier: NCT00321464     History of Changes
Other Study ID Numbers: 20050136
Study First Received: May 2, 2006
Results First Received: December 10, 2010
Last Updated: January 25, 2017

Keywords provided by Amgen:
Bone metastases
Breast cancer
Surgery to Bone

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Neoplasms by Site
Breast Diseases
Bone Marrow Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on May 25, 2017