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

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Involutional Osteoporosis

Treatments: Drug: ONO-5920

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212667

ONO-5920-02

Details and patient eligibility

About

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

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind