NCT00212628CompletedPhase 3
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Ono Pharmaceutical Co., Ltd.11 sites in 1 country444 target enrollmentStarted: June 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ono Pharmaceutical Co., Ltd.
- Enrollment
- 444
- Locations
- 11
- Primary Endpoint
- New fragility vertebral fracture
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
New fragility vertebral fracture
Secondary Outcomes
- New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), lower back pain.
Investigators
Study Sites (11)
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