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

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Osteopenia; Osteoporosis

Treatments: Drug: ONO-5334

Study type: Interventional

Funder types: Industry

Identifiers

NCT00532337

ONO-5334POE003

Details and patient eligibility

About

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

Enrollment: 285 patients

Sex: Female

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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 exclusion criteria as specified in the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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285 participants in 5 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

E1

Experimental group

Treatment:

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

E2

Experimental group

Treatment:

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

E3

Experimental group

Treatment:

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

A

Active Comparator group

Treatment:

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334

Drug: ONO-5334