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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:
National Cancer Institute (NCI)
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, 2016
Last verified: October 2016
Results First Received: October 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      323 100.0%      322 100.0%      645 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   0.3%      1   0.3%      2   0.3% 
Asian      7   2.2%      4   1.2%      11   1.7% 
Native Hawaiian or Other Pacific Islander      2   0.6%      1   0.3%      3   0.5% 
Black or African American      42  13.0%      50  15.5%      92  14.3% 
White      261  80.8%      256  79.5%      517  80.2% 
More than one race      0   0.0%      1   0.3%      1   0.2% 
Unknown or Not Reported      10   3.1%      9   2.8%      19   2.9% 
Region of Enrollment 
[Units: Participants]
     
United States   323   321   644 
Canada   0   1   1 
ECOG Performance Status [1] 
[Units: Participants]
     
 205   205   410 
 105   105   210 
 13   12   25 
[1] Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).
Prior Skeletal Related Event 
[Units: Participants]
     
Yes   42   40   82 
No   281   282   563 


  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
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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: 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: CALGB-90202
U10CA031946 ( US NIH Grant/Contract Award Number )
CAN-NCIC-PRC2
CDR0000353209 ( Registry Identifier: NCI Physician Data Query )
Study First Received: March 8, 2004
Results First Received: October 27, 2014
Last Updated: October 27, 2016