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Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00330759
First received: May 25, 2006
Last updated: July 14, 2014
Last verified: July 2014
Results First Received: December 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, 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 21 June 2006 through 16 May 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1779 participants were enrolled in the study. Three participants from one site were excluded from all analyses because Institutional Review Board (IRB) review activities and oversight were not ensured.

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

Participant Flow:   Overall Study
    Zoledronic Acid   Denosumab
STARTED   890   886 
Received Investigational Product   878   878 
COMPLETED   178   180 
NOT COMPLETED   712   706 
Death                316                310 
Disease progression                104                126 
Withdrawal by Subject                143                124 
Adverse Event                48                36 
Participant request                31                22 
Lost to Follow-up                16                22 
Noncompliance                15                17 
Physician Decision                1                2 
Protocol deviation                0                2 
Ineligibility determined                2                1 
Other                36                44 



  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.
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Reporting Groups
  Description
Zoledronic Acid Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
Denosumab Denosumab 120 mg by subcutaneous injection with an 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]
 890   886   1776 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.6  (10.7)   59.3  (11.4)   59.9  (11.1) 
Gender 
[Units: Participants]
     
Female   338   298   636 
Male   552   588   1140 
Race/Ethnicity, Customized 
[Units: Participants]
     
White or Caucasian   770   770   1540 
Black or African American   29   20   49 
Hispanic or Latino   36   49   85 
Asian   44   36   80 
Japanese   1   3   4 
American Indian or Alaska Native   2   0   2 
Other   8   8   16 
Tumor Type Stratification Factor 
[Units: Participants]
     
Multiple myeloma   93   86   179 
Other   452   457   909 
Non-small cell lung cancer   345   343   688 
Previous Skeletal-Related Event Stratification Factor 
[Units: Participants]
     
Yes   446   440   886 
No   444   446   890 
Systematic Anti-Cancer Therapy Stratification Factor 
[Units: Participants]
     
Yes   747   746   1493 
No   143   140   283 


  Outcome Measures
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1.  Primary:   Time to the First On-Study Skeletal-Related Event (Non-Inferiority)   [ Time Frame: up to 33 months ]

2.  Secondary:   Time to First On-Study Skeletal-Related Event (Superiority)   [ Time Frame: up to 33 months ]

3.  Secondary:   Time to the First-and-Subsequent On-Study Skeletal-Related Event   [ Time Frame: up to 33 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
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  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: NCT00330759     History of Changes
Other Study ID Numbers: 20050244
Study First Received: May 25, 2006
Results First Received: December 9, 2010
Last Updated: July 14, 2014