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

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Alendronate sodium hydrate; Drug: Placebo; Drug: Denosumab

• Registration Number: NCT00680953
• Lead Sponsor: 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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-20
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Results First Submitted: 2013-07-12
• Results First Submitted QC: 2014-01-24
• Results First Posted: 2014-02-26
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1262

Inclusion Criteria

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

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Exclusion Criteria

• Any underlying condition,(other than BMD) that might have resulted in abnormal bone metabolism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Alendronate sodium hydrate	Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm).
2	Placebo	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).
1	Denosumab	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).

Primary Outcome Measures

Name	Time	Method
Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo	Baseline to 24 months

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.	Baseline to 24 Months	The results are expressed as a percentage by Kaplan-Meier estimate.
The Percentage of Non-vertebral Fractures	Baseline to 24 Months	The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures