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: Minodronic acid hydrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212628

ONO-5920-04

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.

Enrollment: 444 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who was included in study ONO-5920-02 and completed the medication for two years
2. Other inclusion criteria as specified in the study protocol

Exclusion criteria

1. Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator
2. Patients having secondary osteoporosis or another condition that presents low bone mass
3. Other exclusion criteria as specified in the study protocol

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)