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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 444
Inclusion Criteria
- Patients who was included in study ONO-5920-02 and completed the medication for two years
- Other inclusion criteria as specified in the study protocol
Exclusion Criteria
- Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator
- Patients having secondary osteoporosis or another condition that presents low bone mass
- 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
Kanto Region Facility
🇯🇵Kanto, Japan
Kyushu Region Facility
🇯🇵Kyushu, Japan
Kinki Region Facility
🇯🇵Kinki, Japan
Hokuriku Region Facility
🇯🇵Hokuriku, Japan
Shikoku Region Facility
🇯🇵Shikoku Region Facility, Japan
Hokkaido Region Facility
🇯🇵Hokkaido, Japan
Tohoku Region Facility
🇯🇵Tohoku, Japan