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

Phase 2

Completed

• Conditions: Osteoporosis; Osteopenia
• Interventions: Drug: ONO-5334

• Registration Number: NCT00532337
• Lead Sponsor: Ono Pharma USA Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-20
• Study Start: 2007-10
• Primary Completion: 2010-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 285

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	ONO-5334	-
P	ONO-5334	-
E1	ONO-5334	-
E2	ONO-5334	-
E3	ONO-5334	-

Primary Outcome Measures

Name	Time	Method
Mean bone mineral density of the lumbar spine (L 1-4 BMD)	12 months

Secondary Outcome Measures

Name	Time	Method
Bone mineral density at hip, Biochemical markers of bone turnover	during course of treatment of 12 months

Trial Locations

Locations (1)

Andromed Noord Groningen; 🇳🇱 Damsterdiep 9, Groningen, Netherlands