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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ono Pharmaceutical Co. Ltd
• Collaborator: Astellas Pharma Inc
• Treatments: Diphosphonates

Criteria

Inclusion Criteria:

1. Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis

2. Patients having radiographically confirmed vertebral (T4-L4) fractures

3. 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 on X-ray that affect evaluation of vertebral fracture

3. Patients that have been administered bisphosphonate derivatives

4. Other exclusion criteria as specified in the study protocol