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Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

This study has been completed.
Sponsor:
Collaborators:
Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00079001
First received: March 8, 2004
Last updated: October 27, 2014
Last verified: October 2014
Results First Received: October 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Metastatic Cancer
Prostate Cancer
Interventions: Drug: zoledronic acid
Other: placebo
Drug: androgen deprivation therapy
Drug: GnRH agonist
Dietary Supplement: Calcium supplement
Dietary Supplement: Vitamin D

  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
Between January 2004 and May 2012, 645 participants were registered and randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zoledronic Acid + Androgen Deprivation Therapy 4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
Placebo + Androgen Deprivation Therapy Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.

Participant Flow:   Overall Study
    Zoledronic Acid + Androgen Deprivation Therapy     Placebo + Androgen Deprivation Therapy  
STARTED     323     322  
COMPLETED     323     322  
NOT COMPLETED     0     0  



  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 + Androgen Deprivation Therapy 4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
Placebo + Androgen Deprivation Therapy Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
Total Total of all reporting groups

Baseline Measures
    Zoledronic Acid + Androgen Deprivation Therapy     Placebo + Androgen Deprivation Therapy     Total  
Number of Participants  
[units: participants]
  323     322     645  
Age  
[units: years]
Median ( Inter-Quartile Range )
  66.1  
  ( 60.0 to 72.5 )  
  66.7  
  ( 60.2 to 73.6 )  
  66.3  
  ( 60.0 to 73.0 )  
Gender  
[units: participants]
     
Female     0     0     0  
Male     323     322     645  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     1     2  
Asian     7     4     11  
Native Hawaiian or Other Pacific Islander     2     1     3  
Black or African American     42     50     92  
White     261     256     517  
More than one race     0     1     1  
Unknown or Not Reported     10     9     19  
Region of Enrollment  
[units: participants]
     
United States     323     321     644  
Canada     0     1     1  
ECOG Performance Status [1]
[units: participants]
     
0     205     205     410  
1     105     105     210  
2     13     12     25  
Prior Skeletal Related Event  
[units: participants]
     
Yes     42     40     82  
No     281     282     563  
[1] Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).



  Outcome Measures
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1.  Primary:   Time to First Skeletal Related Event   [ Time Frame: Up to 10 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 10 years ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Up to 10 years ]


  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: Matthew Smith, MD, PhD
Organization: Massachusetts General Hospital
e-mail: smith.matthew@mgh.harvard.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00079001     History of Changes
Obsolete Identifiers: NCT00698308
Other Study ID Numbers: CDR0000353209, U10CA031946, CALGB-90202, CAN-NCIC-PRC2
Study First Received: March 8, 2004
Results First Received: October 27, 2014
Last Updated: October 27, 2014
Health Authority: United States: Food and Drug Administration