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 4, 2014
Last verified: February 2014
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.
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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 subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
Total Total of all reporting groups

Baseline Measures
    Zoledronic Acid     Denosumab     Total  
Number of Participants  
[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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