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

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ClinicalTrials.gov Identifier: NCT00680953
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : February 26, 2014
Last Update Posted : March 12, 2015
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Denosumab Drug: Placebo Drug: Alendronate sodium hydrate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1262 participants
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)
Study Start Date : May 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

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.

Publications of Results:
Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT00680953     History of Changes
Other Study ID Numbers: AMG162-A-J301
First Posted: May 20, 2008    Key Record Dates
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