ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

Study Overview
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Brief Summary
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This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.

Official Title
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A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.

Conditions
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Osteoporosis, Bone Loss, Age-Related

Intervention / Treatment
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* Drug: YM529 / ONO-5920


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose bone mineral density is <70% of Young Adult Mean (YAM), or <80% of YAM who have fragile fracture history Patients can walk on his/her own Written informed consent has been obtained from the patient. Exclusion Criteria: Sequential osteoporosis patients or patients with other disorders showing low bone mass Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method Patients who are unable to keep raising or standing for ≥30 min Patients with peptic ulcer Patients who have experienced anamnesis or gastrectomy (total extraction)

Ages Eligible for Study
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Minimum Age: 45 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. Monthly - Dose 1<br>Monthly intermittent administration, dose 1 | Drug: YM529 / ONO-5920<br>* Oral<br>* Other names: Minodronic acid;|
| Experimental: 2. Monthly - Dose 2<br>Monthly intermittent administration, dose 2 | Drug: YM529 / ONO-5920<br>* Oral<br>* Other names: Minodronic acid;|
| Active Comparator: 3. Daily<br>Daily administration | Drug: YM529 / ONO-5920<br>* Oral<br>* Other names: Minodronic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method |  | At the final evaluation point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-course changes in the percent change of bone metabolism markers |  | Through the treatment period | 
| Time-course changes in the total femoral bone mineral density by the DXA method |  | Through the treatment period | 
| Assessment of adverse events, lab test values |  | Through the treatment period | 
| Frequency of fracture |  | At the final evaluation point | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONO-5920, YM529, Bone mineral density, Minodronic acid