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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

May 16, 2008
July 7, 2014
May 2008
June 2012   (final data collection date for primary outcome measure)
Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Reduction of the incident rate of fragilty vertebral fractures with denosumab compared to placebo [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Safety profile of denosumab [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00680953 on ClinicalTrials.gov Archive Site
  • The Percentage of Non-vertebral Fractures [ Time Frame: Baseline to 24 Months ] [ Designated as safety issue: No ]
    The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures
  • Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo. [ Time Frame: Baseline to 24 Months ] [ Designated as safety issue: No ]
    The results are expressed as a percentage by Kaplan-Meier estimate.
  • Incident rate on non-vertebral fractures [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Incident rate of hip fractures [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Assessment of adverse events and laboratory test changes from baseline [ Time Frame: 24 months and 36 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
A Randomized, Double-Blind, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of Denosumab in Japanese Osteoporotic Subjects With Prevalent Fragility Vertebral Fracture(s)

Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoporosis
  • Drug: Denosumab
    Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
  • Drug: Placebo
    Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
  • Drug: Alendronate sodium hydrate
    Oral tablet once a week for 24 months
  • Experimental: 1
    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).
    Intervention: Drug: Denosumab
  • Placebo Comparator: 2
    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).
    Intervention: Drug: Placebo
  • Active Comparator: 3
    Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
    Intervention: Drug: Alendronate sodium hydrate
Nakamura T, Matsumoto T, Sugimoto T, Hosoi T, Miki T, Gorai I, Yoshikawa H, Tanaka Y, Tanaka S, Sone T, Nakano T, Ito M, Matsui S, Yoneda T, Takami H, Watanabe K, Osakabe T, Shiraki M, Fukunaga M. Clinical Trials Express: Fracture Risk Reduction With Denosumab in Japanese Postmenopausal Women and Men With Osteoporosis: Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT). J Clin Endocrinol Metab. 2014 Jul;99(7):2599-607. doi: 10.1210/jc.2013-4175. Epub 2014 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1262
July 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Involutional (postmenopausal and senile) osteoporosis with prevalent fragility vertebral fractures

Exclusion Criteria:

  • Any underlying condition,(other than BMD) that might have resulted in abnormal bone metabolism
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00680953
AMG162-A-J301
Yes
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
Daiichi Sankyo Co., Ltd.
Not Provided
Study Chair: Daiichi Sankyo R&D Division, Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP