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: January 24, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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: January 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on April 17, 2014