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Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00980174
First received: September 17, 2009
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
Results First Received: October 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Low Bone Mass
Low Bone Mineral Density
Males With Osteoporosis
Osteopenia
Osteoporosis
Interventions: Drug: 60 mg denosumab
Other: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo No text entered.
Denosumab 60 mg Q6M No text entered.

Participant Flow:   Overall Study
    Placebo     Denosumab 60 mg Q6M  
STARTED     121     121  
COMPLETED     117     111  
NOT COMPLETED     4     10  
Withdrawal by Subject                 1                 4  
Adverse Event                 0                 3  
Ineligibility determined                 2                 1  
Death                 1                 1  
Other                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo No text entered.
Denosumab 60 mg Q6M No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo     Denosumab 60 mg Q6M     Total  
Number of Participants  
[units: participants]
 		  121     121     242  
Age  
[units: years]
Mean ± Standard Deviation 		  65.0  ± 9.1     64.9  ± 10.5     65.0  ± 9.8  
Gender  
[units: Participants]
 		     
Female     0     0     0  
Male     121     121     242  
Race/Ethnicity, Customized  
[units: Participants]
 		     
White or Caucasian     107     121     228  
Hispanic or Latino     10     0     10  
Asian     2     0     2  
Black or African American     1     0     1  
Native Hawaiian or Pacific Islander     1     0     1  
Region of Enrollment  
[units: Participants]
 		     
Europe     78     87     165  
North America     43     34     77  



  Outcome Measures
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1.  Primary:   Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12   [ Time Frame: From Baseline to 12 Months ]
  Show Outcome Measure 1

2.  Secondary:   Total Hip Bone Mineral Density Percent Change From Baseline at Month 12   [ Time Frame: From Baseline to 12 Months ]
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3.  Secondary:   Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12   [ Time Frame: From Baseline to 12 Months ]
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4.  Secondary:   Trochanter Bone Mineral Density Percent Change From Baseline at Month 12   [ Time Frame: From Baseline to 12 Months ]
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5.  Secondary:   Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12   [ Time Frame: From Baseline to 12 Months ]
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6.  Secondary:   Serum Type 1 Collagen C-telopeptide (CTX) Percent Change From Baseline at Day 15   [ Time Frame: From Baseline to Day 15 ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided by Amgen

Publications automatically indexed to this study:


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00980174     History of Changes
Other Study ID Numbers: 20080098
Study First Received: September 17, 2009
Results First Received: October 31, 2012
Last Updated: January 22, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products (FAMHP)
Canada: Health Canada
Denmark: Central Ethics Committee
Denmark: Danish Medicines Agency
Denmark: Laegemiddelstyrelsen
Denmark: Ministry of Health
EU: CHMP
European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ministry of Health
Poland: Drug Institut
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Central Ethics Committee
Sweden: Lakemedelsverket
Sweden: Medical Products Agency
United States: Food and Drug Administration