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A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00306189
First received: March 21, 2006
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
Results First Received: December 22, 2009  
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: 100 mg AMG 162
Drug: 60 mg AMG 162
Drug: 14 mg 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
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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
Denosumab 14 mg Q6M No text entered.
Denosumab 60 mg Q6M No text entered.
Denosumab 100 mg Q6M No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Denosumab 14 mg Q6M     Denosumab 60 mg Q6M     Denosumab 100 mg Q6M     Placebo  
STARTED     57     56     56     57  
COMPLETED     48     50     45     52  
NOT COMPLETED     9     6     11     5  
Physician Decision                 0                 0                 0                 1  
Adverse Event                 3                 3                 2                 2  
Withdrawal by Subject                 4                 2                 8                 1  
Ineligibility determined                 1                 1                 1                 1  
Other                 1                 0                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Denosumab 14 mg Q6M No text entered.
Denosumab 60 mg Q6M No text entered.
Denosumab 100 mg Q6M No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Denosumab 14 mg Q6M     Denosumab 60 mg Q6M     Denosumab 100 mg Q6M     Placebo     Total  
Number of Participants  
[units: participants]
 		  53     54     50     55     212  
Age  
[units: Years]
Mean ± Standard Deviation 		  65.9  ± 7.1     65.1  ± 6.3     64.6  ± 7.1     64.6  ± 7     65.1  ± 6.8  
Gender  
[units: Participants]
 		         
Female     53     54     50     55     212  
Male     0     0     0     0     0  



  Outcome Measures

1.  Primary:   Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12   [ Time Frame: 12 months ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Measure Description Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
Time Frame 12 months  
Safety Issue No  

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.
All subjects who received >= 1 dose of investigational product and have a baseline and >= 1 post baseline measurement at the lumbar spine.

Reporting Groups
  Description
Placebo No text entered.
Denosumab 14 mg Q6M No text entered.
Denosumab 60 mg Q6M No text entered.
Denosumab 100 mg Q6M No text entered.

Measured Values
    Placebo     Denosumab 14 mg Q6M     Denosumab 60 mg Q6M     Denosumab 100 mg Q6M  
Number of Participants Analyzed  
[units: participants]
 		  55     53     54     50  
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12  
[units: Percent Change from Baseline]
Mean ( 95% Confidence Interval ) 		  .46  
  ( -.23 to 1.15 )   		  5.71  
  ( 4.76 to 6.65 )   		  6.73  
  ( 5.71 to 7.75 )   		  7.45  
  ( 6.38 to 8.53 )  


Statistical Analysis 1 for Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Groups [1] Placebo vs. Denosumab 100 mg Q6M
Method [2] t-test, 2 sided
P Value [3] <0.0001
Mean Difference (Final Values) [4] 7
95% Confidence Interval ( 5.76 to 8.24 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
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Statistical Analysis 2 for Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Groups [1] Placebo vs. Denosumab 14 mg Q6M
Method [2] t-test, 2 sided
P Value [3] <0.0001
Mean Difference (Final Values) [4] 5.25
95% Confidence Interval ( 4.1 to 6.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12
Groups [1] Placebo vs. Denosumab 60 mg Q6M
Method [2] t-test, 2 sided
P Value [3] <0.0001
Mean Difference (Final Values) [4] 6.27
95% Confidence Interval ( 5.06 to 7.49 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.




  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


Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00306189     History of Changes
Other Study ID Numbers: 20050172, NOT APPRICABLE
Study First Received: March 21, 2006
Results First Received: December 22, 2009
Last Updated: January 20, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare