UMIN ID: UMIN000002322
Registered date:11/08/2009
Administration time-dependent effects of raloxifen in postmenopausal women with osteoporosis
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | postmenopausal osteoporosis |
| Date of first enrollment | 2009/08/01 |
| Target sample size | 64 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Morning-administration of raloxifene Evening-administration of raloxifene |
Outcome(s)
| Primary Outcome | Coagulation and fibrinolysis factors |
|---|---|
| Secondary Outcome | Bone metabolism markers Adverse reactions Bone density |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Female |
| Include criteria | |
| Exclude criteria | Treatment with raloxifene or bisphosphonate in the preceding 12 months Anticoagulant therapy Inpatients Current or previous venous thromboembolism Bedridden subjects Antiphospholipid antibody syndrome Possibility of pregnancy Hypersensitivity to raloxifene Severe hepatic impairment Severe renal dysfunction Other unsuitableness |
Related Information
| Primary Sponsor | Division of Clinical Pharmacology, Department of Pharmacology, School of Medicine, Jichi Medical University |
|---|---|
| Secondary Sponsor | Hokuriku Clinical Research Supporting Center Moka Hospital Kahoku Central Hospital Nagai Internal Medicine Clinic Kanazawa Red Cross Hospital Shin-Kaminokawa Hospital |
| Source(s) of Monetary Support | Japan Research Foundation For Clinical Pharmacology,Japan Osteoporosis Fundation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | Jichi Medical University Clinical Pharmacology |
| scientific contact | |
| Name | Hitoshi Ando |
| Address | 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan Japan |
| Telephone | 0285-58-7388 |
| Affiliation | Jichi Medical University Clinical Pharmacology |