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Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00838201
First received: February 5, 2009
Last updated: November 1, 2013
Last verified: November 2013
Results First Received: July 23, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cancer
Carcinoma
Castrate-Resistant Prostate Cancer
Prostate Cancer
Tumors
Intervention: Drug: 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
First subject enrollment date: 18 February 2009; Last subject enrollment date: 11 May 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only recruited those who were participating in the safety follow-up of 20040138 study at the time, were willing to receive Denosumab, and met the inclusion/exclusion criteria. The first portion of the arm label indicates subjects' treatment groups (Placebo or Denosumab) in the parent study 20040138

Reporting Groups
  Description
Placebo/Denosumab 60 mg SC Q6M Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
Denosumab/Denosumab 60 mg SC Q6M Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study

Participant Flow:   Overall Study
    Placebo/Denosumab 60 mg SC Q6M     Denosumab/Denosumab 60 mg SC Q6M  
STARTED     186     198  
COMPLETED     144     145  
NOT COMPLETED     42     53  
Investigator decision, or other reasons                 2                 3  
Noncompliance                 0                 1  
Administrative decision                 1                 2  
Disease progression                 3                 3  
Consetn withdrawn                 16                 19  
Lost to Follow-up                 4                 3  
Adverse Event                 5                 9  
Death                 11                 13  



  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
Placebo/Denosumab 60 mg SC Q6M Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
Denosumab/Denosumab 60 mg SC Q6M Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
Total Total of all reporting groups

Baseline Measures
    Placebo/Denosumab 60 mg SC Q6M     Denosumab/Denosumab 60 mg SC Q6M     Total  
Number of Participants  
[units: participants]
  186     198     384  
Age  
[units: Years]
Mean ± Standard Deviation
  73  ± 7.1     74.1  ± 6.6     73.6  ± 6.9  
Gender  
[units: Participants]
     
Female     0     0     0  
Male     186     198     384  
Race/Ethnicity, Customized  
[units: Participants]
     
White or Caucasian     153     173     326  
Black or African American     6     8     14  
Hispanic or Latino     26     17     43  
Japanese     1     0     1  



  Outcome Measures

1.  Primary:   Overall Survival Through Month 24   [ Time Frame: 24 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


No publications provided


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00838201     History of Changes
Other Study ID Numbers: 20080537
Study First Received: February 5, 2009
Results First Received: July 23, 2013
Last Updated: November 1, 2013
Health Authority: Canada: Health Canada
Mexico: Ministry of Health
United States: Food and Drug Administration
Czech Republic: Státní ústav pro kontrolu léciv (SUKL)
Finland: Finnish Medicines Agency
Hungary: National Institute for Quality- and Organizational Development in Healthcare and Medicines / National Institute of Pharmacy Directorate
Netherlands: Centrale Commissie Mesgebonden Onderzoek (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Switzerland: Swissmedic