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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00321464
First Posted: May 3, 2006
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Amgen
Results First Submitted: December 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition: Bone Metastases
Interventions: Biological: Denosumab
Drug: Zoledronic Acid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 27 April 2006 through 31 December 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2049 patients were enrolled in the study, but 3 patients were excluded from all analyses because properly documented informed consent was not obtained.

Reporting Groups
  Description
Zoledronic Acid Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
Denosumab Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks

Participant Flow:   Overall Study
    Zoledronic Acid   Denosumab
STARTED   1020   1026 
Received Investigational Product   1014   1019 
COMPLETED   461   468 
NOT COMPLETED   559   558 
Death                169                174 
Disease progression                124                124 
Withdrawal by Subject                117                118 
Participant request                57                61 
Adverse Event                43                28 
Physician Decision                15                14 
Noncompliance                4                10 
Lost to Follow-up                7                8 
Protocol deviation                0                2 
Ineligibility determined                2                1 
Other                21                18 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zoledronic Acid Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
Denosumab Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
Total Total of all reporting groups

Baseline Measures
   Zoledronic Acid   Denosumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 1020   1026   2046 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.6  (11.6)   56.8  (11.5)   56.7  (11.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1011  99.1%      1018  99.2%      2029  99.2% 
Male      9   0.9%      8   0.8%      17   0.8% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White or Caucasian   813   822   1635 
Black or African American   25   26   51 
Hispanic or Latino   59   59   118 
Asian   37   32   69 
Japanese   69   70   139 
Native Hawaiian or Other Pacific Islander   1   1   2 
Other   16   16   32 
Previous Skeletal-Related Event Stratification Factor 
[Units: Participants]
     
Yes   373   378   751 
No   647   648   1295 
Prior Oral Bisphosphonate Use Stratification Factor 
[Units: Participants]
     
Yes   38   42   80 
No   982   984   1966 
Current Chemotherapy Stratification Factor [1] 
[Units: Participants]
     
Yes   408   410   818 
No   612   616   1228 
[1] Defined as within 6 weeks before randomization
Japan Stratification Factor [1] 
[Units: Participants]
     
Yes   67   69   136 
No   953   957   1910 
[1] Participant located in Japan


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)   [ Time Frame: Up to 34 months ]

2.  Secondary:   Time to First On-Study Skeletal-Related Event (Superiority)   [ Time Frame: Up to 34 months ]

3.  Secondary:   Time to First and Subsequent On-Study Skeletal-Related Event   [ Time Frame: Up to 34 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00321464     History of Changes
Other Study ID Numbers: 20050136
First Submitted: May 2, 2006
First Posted: May 3, 2006
Results First Submitted: December 10, 2010
Results First Posted: March 10, 2014
Last Update Posted: March 8, 2017