Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Phase 3

Completed

• Conditions: Involutional Osteoporosis

• Registration Number: NCT00212719
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Primary Completion: 2006-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

1. A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
2. Other inclusion criteria as specified in the study protocol.

Exclusion Criteria

1. Patients having secondary osteoporosis or another condition that presents low bone mass.
2. Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA
3. Patients that have been administered bisphosphonate derivatives.
4. Other exclusion criteria as specified in the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean bone mineral density of the lumbar spine (L2-4 BMD)

Secondary Outcome Measures

Name	Time	Method
Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain