NCT00532337CompletedPhase 2
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ono Pharma USA Inc
- Enrollment
- 285
- Locations
- 1
- Primary Endpoint
- Mean bone mineral density of the lumbar spine (L 1-4 BMD)
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
P
Placebo Comparator
Intervention: ONO-5334 (Drug)
E1
Experimental
Intervention: ONO-5334 (Drug)
E2
Experimental
Intervention: ONO-5334 (Drug)
E3
Experimental
Intervention: ONO-5334 (Drug)
A
Active Comparator
Intervention: ONO-5334 (Drug)
Outcomes
Primary Outcomes
Mean bone mineral density of the lumbar spine (L 1-4 BMD)
Time Frame: 12 months
Secondary Outcomes
- Bone mineral density at hip, Biochemical markers of bone turnover(during course of treatment of 12 months)
Investigators
Study Sites (1)
Loading locations...
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