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

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

Official Title
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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)

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Denosumab
* Drug: Placebo
* Drug: Alendronate sodium hydrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).<br>|
| Placebo Comparator: 2<br>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<br>* Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).<br>|
| Active Comparator: 3<br>Alendronate sodium hydrate oral tablets weekly + daily calcium and vitamin D supplements for 24 months (open label reference arm). | Drug: Alendronate sodium hydrate<br>* Oral tablet once a week for 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo |  | Baseline to 24 months | 

Secondary Outcome Measures

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