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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 17, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Reduction in the incidence rate of fragility vertebral fractures in osteoporotic subjects treated 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 ]

Secondary Outcome Measures:
  • The incidence rate of non-vertebral fractures [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • The incidence rate of hip fractures [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Assessment of adverse events and changes from baseline in laboratory tests. [ Time Frame: 24 months and 36 months ] [ Designated as safety issue: Yes ]

Enrollment: 1100
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
Last Updated: July 17, 2012
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 May 19, 2013