Osteopenia, Osteoporosis
Conditions
Keywords
ONO-5334, osteoporosis, osteopenia
Brief summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.
Interventions
DRUGONO-5334
Placebo - 24/mos.
Sponsors
Ono Pharma USA Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 75 Years
Healthy volunteers
No
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
1. 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. 2. Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive. 3. 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. 4. Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD. 5. Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism. 6. Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean bone mineral density of the lumbar spine (L 1-4 BMD) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Bone mineral density at hip, Biochemical markers of bone turnover | during course of treatment of 12 months |
Countries
Netherlands
Outcome results
None listed