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Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00242567
First received: October 19, 2005
Last updated: April 14, 2014
Last verified: April 2014
Results First Received: January 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Zoledronic Acid
Drug: Androgen Deprivation Therapy (ADT)

  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
552 patients enrolled, but 30 patients were excluded due to GCP issues in one country.

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
Early Group Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.

Participant Flow:   Overall Study
    Early Group     Delayed Group  
STARTED     259     263  
Received at Least 1 Dose of Study Drug     259     72  
Never Received Study Drug     0     191  
COMPLETED     93     123  
NOT COMPLETED     166     140  
Adverse Event                 70                 43  
Disease Progression                 17                 22  
Symptomatic deterioration                 9                 3  
Lack of Efficacy                 2                 2  
Lost to Follow-up                 9                 19  
Withdrawal by Subject                 33                 28  
Protocol Violation                 12                 12  
Use of an inhibitor of bone resorption                 0                 2  
Unknown                 14                 9  



  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
Early Group Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed Group Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
Total Total of all reporting groups

Baseline Measures
    Early Group     Delayed Group     Total  
Number of Participants  
[units: participants]
  259     263     522  
Age  
[units: years]
Mean ± Standard Deviation
  69.4  ± 8.46     70.2  ± 8.26     69.8  ± 8.37  
Gender  
[units: participants]
     
Female     0     0     0  
Male     259     263     522  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer   [ Time Frame: 18 months ]

2.  Secondary:   Overall Survival at 18 Months and 3 Years   [ Time Frame: month 18, year 3 ]

3.  Secondary:   Time to Occurrence of Skeletal Related Event or Death   [ Time Frame: 18 Months ]

4.  Secondary:   Skeletal-related Event(SRE)-Free Survival   [ Time Frame: 36 months ]

5.  Secondary:   Time to Occurrence of Skeletal Related Event or Death   [ Time Frame: 36 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: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00242567     History of Changes
Other Study ID Numbers: CZOL446E2432
Study First Received: October 19, 2005
Results First Received: January 29, 2013
Last Updated: April 14, 2014
Health Authority: Australia: National Health and Medical Research Council
Brazil: Ministry of Health
China: Ministry of Health
Korea: Food and Drug Administration
Kuwait: Joint Committee for the Protection of Human Subjects in Research
Lebanon: Ministry of Public Health
New Zealand: Ministry of Health
Saudi Arabia: Ministry of Health
Taiwan : Food and Drug Administration
Thailand: Food and Drug Administration