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Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00321620
First received: May 2, 2006
Last updated: February 19, 2016
Last verified: February 2016
Results First Received: December 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Bone Metastases
Interventions: Drug: zoledronic acid
Biological: denosumab

  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 12 May 2006 through 18 December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1904 participants were enrolled, however 3 were excluded from all analyses as Institutional Review Board 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 subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks

Participant Flow:   Overall Study
    Zoledronic Acid   Denosumab
STARTED   951   950 
Received Investigational Product   946   942 
COMPLETED   208   228 
NOT COMPLETED   743   722 
Death                269                294 
Withdrawal by Subject                164                147 
Disease progression                113                117 
Adverse Event                43                56 
Lost to Follow-up                13                9 
Physician Decision                4                1 
Noncompliance                14                7 
Protocol deviation                4                3 
Ineligibility determined                2                3 
Participant request                75                52 
Other                42                33 



  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 a subcutaneous denosumab placebo once every 4 weeks
Denosumab Denosumab 120 mg subcutaneously 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]
 951   950   1901 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.0  (8.4)   70.5  (8.7)   70.8  (8.6) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   951   950   1901 
Race/Ethnicity, Customized 
[Units: Participants]
     
White or Caucasian   810   829   1639 
Black or African American   35   38   73 
Hispanic or Latino   57   45   102 
Asian   26   22   48 
Native Hawaiian or Other Pacific Islander   1   1   2 
Other   22   15   37 
Prostate-Specific Antigen (PSA) Stratification Factor 
[Units: Participants]
     
PSA level < 10 ng/mL   145   145   290 
PSA level ≥ 10 ng/mL   806   805   1611 
Previous Skeletal-Related Event (SRE) Stratification Factor 
[Units: Participants]
     
Yes   231   232   463 
No   720   718   1438 
Current Prostate Cancer Chemotherapy Stratification Factor [1] 
[Units: Participants]
     
Yes   132   132   264 
No   819   818   1637 
[1] Defined as within 6 weeks before randomization


  Outcome Measures
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1.  Primary:   Time to the First On-Study SRE (Non-inferiority)   [ Time Frame: Up to 40.5 months ]

2.  Secondary:   Time to the First On-Study SRE (Superiority)   [ Time Frame: Up to 40.5 months ]

3.  Secondary:   Time to the First-And-Subsequent On-Study SRE   [ Time Frame: Up to 40.5 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: NCT00321620     History of Changes
Other Study ID Numbers: 20050103
Study First Received: May 2, 2006
Results First Received: December 10, 2010
Last Updated: February 19, 2016
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