Overview

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