A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00089791
First received: August 13, 2004
Last updated: July 16, 2014
Last verified: July 2014
Results First Received: July 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: placebo
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 Enrolled: 03-Aug-2004 Last Subject Enrolled: 01-Jun-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 subcutaneously once every 6 months for 3 years.
Denosumab 60 mg Q6M Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.

Participant Flow:   Overall Study
    Placebo     Denosumab 60 mg Q6M  
STARTED     3906     3902  
Received Study Medication     3883     3879  
Safety Analysis Set     3876 [1]   3886  
COMPLETED     3206     3272  
NOT COMPLETED     700     630  
Physician Decision                 6                 3  
Adverse Event                 81                 93  
Withdrawal by Subject                 403                 344  
Death                 78                 62  
Disease progression                 7                 3  
Ineligibility determined                 12                 9  
Lost to Follow-up                 57                 57  
Noncompliance                 17                 13  
Other                 20                 32  
Protocol deviation                 12                 10  
Requirement for alternative therapy                 7                 4  
[1] 7 participants in the placebo arm received ≥1 dose of denosumab & were analyzed in the denosumab arm



  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 subcutaneously once every 6 months for 3 years.
Denosumab 60 mg Q6M Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
Total Total of all reporting groups

Baseline Measures
    Placebo     Denosumab 60 mg Q6M     Total  
Number of Participants  
[units: participants]
  3906     3902     7808  
Age  
[units: Years]
Mean ± Standard Deviation
  72.3  ± 5.2     72.3  ± 5.2     72.3  ± 5.2  
Gender  
[units: Participants]
     
Female     3906     3902     7808  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
     
White or Caucasian     3629     3609     7238  
Black or African American     27     30     57  
Hispanic or Latino     232     241     473  
Asian     8     9     17  
Japanese     4     7     11  
Native Hawaiian or Other Pacific Islander     2     0     2  
Other     4     6     10  



  Outcome Measures
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1.  Primary:   Number of Participants With New Vertebral Fractures   [ Time Frame: 36 months ]

2.  Secondary:   Number of Participants With Nonvertebral Fractures   [ Time Frame: 36 months ]

3.  Secondary:   Number of Participants With a Hip Fracture   [ 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
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:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00089791     History of Changes
Other Study ID Numbers: 20030216
Study First Received: August 13, 2004
Results First Received: July 2, 2010
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration