Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis (DIRECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00680953
First received: May 16, 2008
Last updated: July 7, 2014
Last verified: July 2014
Results First Received: July 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Denosumab
Drug: Placebo
Drug: Alendronate sodium hydrate

  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 Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
Placebo Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
Alendronate Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).

Participant Flow:   Overall Study
    Denosumab     Placebo     Alendronate  
STARTED     500     511     251  
COMPLETED     414     416     204  
NOT COMPLETED     86     95     47  



  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.
The demography information shows the number of participants included in the full analysis set (FAS) for efficacy analyses, which includes all randomized subjects except for those who did not have osteoporosis, did not receive the investigational product, or had no available efficacy data after the first dose of the investigational product.

Reporting Groups
  Description
Denosumab Denosumab (subcutaneously - every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
Placebo Placebo (subcutaneously every 6 months) + daily calcium and vitamin D supplements for 24 months, followed by a 12-month period of denosumab (subcutaneously - every 6 months).
Alendronate Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
Total Total of all reporting groups

Baseline Measures
    Denosumab     Placebo     Alendronate     Total  
Number of Participants  
[units: participants]
  472     480     242     1194  
Age  
[units: years]
Mean ± Standard Deviation
  69.9  ± 7.36     69.0  ± 7.67     70.2  ± 7.31     69.6  ± 7.49  
Gender  
[units: participants]
       
Female     449     456     230     1135  
Male     23     24     12     59  
Region of Enrollment  
[units: participants]
       
Japan     472     480     242     1194  
the number of participants with vertebral fractures [1]
[units: Participants]
  466     471     237     1174  
[1] the number of participants with vertebral fractures



  Outcome Measures
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1.  Primary:   Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo   [ Time Frame: Baseline to 12 weeks ]

2.  Secondary:   The Percentage of Non-vertebral Fractures   [ Time Frame: Baseline to 24 Months ]

3.  Secondary:   Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.   [ Time Frame: Baseline to 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: H. Takami
Organization: Daiichi Sankyo Co., Ltd.
phone: +81 3 5740 3445
e-mail: takami.hideo.hs@daiichisankyo.co.jp


Publications of Results:

Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00680953     History of Changes
Other Study ID Numbers: AMG162-A-J301
Study First Received: May 16, 2008
Results First Received: July 12, 2013
Last Updated: July 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare