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

Phase 3

Completed

• Conditions: Involutional Osteoporosis

• Registration Number: NCT00212628
• 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: 2004-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 444

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
New fragility vertebral fracture

Secondary Outcome Measures

Name	Time	Method
New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), lower back pain.

Trial Locations

Locations (9)

Chubu Region Facility; 🇯🇵 Chubu, Japan

Chugoku Region Facility; 🇯🇵 Chugoku, Japan

Hokkaido Region Facility; 🇯🇵 Hokkaido, Japan

Hokuriku Region Facility; 🇯🇵 Hokuriku, Japan

Kanto Region Facility; 🇯🇵 Kanto, Japan

Kinki Region Facility; 🇯🇵 Kinki, Japan

Kyushu Region Facility; 🇯🇵 Kyushu, Japan

Shikoku Region Facility; 🇯🇵 Shikoku Region Facility, Japan

Tohoku Region Facility; 🇯🇵 Tohoku, Japan