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AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00089674
First Posted: August 11, 2004
Last Update Posted: March 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
Results First Submitted: July 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: AMG 162
Drug: Placebo

  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 Enrolled: 15-Apr-2004 Last Subject Enrolled: 29-Apr-2005

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
Placebo Placebo administered subcutaneous every 6 months for 3 years
Denosumab 60 mg Q6M Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years

Participant Flow:   Overall Study
    Placebo   Denosumab 60 mg Q6M
STARTED   734   734 
Received Study Drug   730   726 
COMPLETED   445   467 
NOT COMPLETED   289   267 
Physician Decision                4                2 
Adverse Event                23                29 
Withdrawal by Subject                143                127 
Death                43                43 
Disease progression                21                23 
Ineligibility determined                8                10 
Lost to Follow-up                21                17 
Noncompliance                7                3 
Other                5                9 
Requirement for alternative therapy                14                4 



  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 Placebo administered subcutaneous every 6 months for 3 years
Denosumab 60 mg Q6M Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
Total Total of all reporting groups

Baseline Measures
   Placebo   Denosumab 60 mg Q6M   Total 
Overall Participants Analyzed 
[Units: Participants]
 734   734   1468 
Age 
[Units: Years]
Mean (Standard Deviation)
 75.5  (7.1)   75.3  (7)   75.4  (7.1) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   734   734   1468 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   3   5   8 
Japanese   4   1   5 
American Indian or Alaska Native   2   0   2 
Other   3   0   3 
White or Caucasian   609   615   1224 
Black or African American   32   36   68 
Hispanic or Latino   81   77   158 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24   [ Time Frame: 24 months ]

2.  Secondary:   Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24   [ Time Frame: 24 months ]

3.  Secondary:   Total Hip Bone Mineral Density Percent Change From Baseline at Month 24   [ Time Frame: 24 months ]

4.  Secondary:   Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36   [ Time Frame: 36 months ]

5.  Secondary:   Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36   [ Time Frame: 36 months ]

6.  Secondary:   Total Hip Bone Mineral Density Percent Change From Baseline at Month 36   [ Time Frame: 36 months ]

7.  Secondary:   Number of Participants With Any Fracture Through Month 36   [ Time Frame: 36 months ]

8.  Secondary:   Number of Participants With a New Vertebral Fracture Through Month 36   [ Time Frame: 36 months ]

9.  Secondary:   Time to First Clinical Fracture Through Month 36   [ Time Frame: 36 months ]

10.  Secondary:   Number of Participants With Any Fracture 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
No text entered.


  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: NCT00089674     History of Changes
Other Study ID Numbers: 20040138
HALT Prostate Cancer
First Submitted: August 9, 2004
First Posted: August 11, 2004
Results First Submitted: July 2, 2010
Results First Posted: June 3, 2014
Last Update Posted: March 21, 2016