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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00680953
First Posted: May 20, 2008
Last Update Posted: March 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
  Purpose
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)

Condition Intervention Phase
Osteoporosis Drug: Denosumab Drug: Placebo Drug: Alendronate sodium hydrate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):

Primary Outcome Measures:
  • Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo [ Time Frame: Baseline to 24 months ]

Secondary Outcome Measures:
  • The Percentage of Non-vertebral Fractures [ Time Frame: Baseline to 24 Months ]
    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 ]
    The results are expressed as a percentage by Kaplan-Meier estimate.


Enrollment: 1262
Study Start Date: May 2008
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: Denosumab
Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
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).
Drug: Placebo
Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).
Active Comparator: 3
Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
Drug: Alendronate sodium hydrate
Oral tablet once a week for 24 months

  Eligibility

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680953


Locations
Japan
Fukuoka, Japan
Osaka, Japan
Sapporo, Japan
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
Study Chair: Daiichi Sankyo R&D Division, Daiichi Sankyo Co., Ltd.
  More Information

Publications:
Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT00680953     History of Changes
Other Study ID Numbers: AMG162-A-J301
First Submitted: May 16, 2008
First Posted: May 20, 2008
Results First Submitted: July 12, 2013
Results First Posted: February 26, 2014
Last Update Posted: March 12, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs