Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.

Official Title
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A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

Conditions
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Osteoporosis, Osteopenia

Intervention / Treatment
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* Drug: ONO-5334
* Drug: ONO-5334
* Drug: ONO-5334
* Drug: ONO-5334
* Drug: ONO-5334


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (T-score <-1 and >2.5) at the lumbar spine (L1 to L4) or total hip. Exclusion Criteria: Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score <-3.5) at the lumbar spine (L1 to L4) or total hip. Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive. Osteopenia patients (T-score <-1 and >-2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR Osteopenia patients (T-score <-1 and >-2.5) who have two or more vertebral fragility fractures between T4 and L4 inclusive. Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD. Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism. Other exclusion criteria as specified in the study protocol.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: ONO-5334<br>* Placebo - 24/mos.<br>|
| Experimental: E1<br> | Drug: ONO-5334<br>* 100mg QD /24 months<br>|
| Experimental: E2<br> | Drug: ONO-5334<br>* 50mg BID /24 mos.<br>|
| Experimental: E3<br> | Drug: ONO-5334<br>* 300mg QD /24 mos.<br>|
| Active Comparator: A<br> | Drug: ONO-5334<br>* Alendronate 70mg once weekly / 24 mos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean bone mineral density of the lumbar spine (L 1-4 BMD) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density at hip, Biochemical markers of bone turnover |  | during course of treatment of 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONO-5334, osteoporosis, osteopenia