steroid-associated osteonecrosis of the femoral head
Conditions
Interventions
administration of pitavastatin 2mg/day for patients with high LDL-cholesterol
no administration of pitavastat for patients without high LDL-cholesterol
Sponsors
Department of Hematology, Endocrinology and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.patients scheduled for high dose steroid therapy (steroid pulse therapy and 1mg/kg/day or more of prednisolone) 2.inpatients and outpatients 3.having written informed consent
Exclusion criteria
Exclusion criteria: 1.history of usage of high dose steroid (1mg/kg/day or more of prednisolone) within 6 month 2.patients corresponding to the contraindication of pitavastatin; history of hypersensitivity to pitavastatin, severe liver failure or biliary obstruction, administration of cyclosporine, women who are or may be pregnant and nursing woman 3.patients who investigator has determined inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The incidence of osteonecrosis of the femoral head (12 month) 2.The characteristic changes of osteonecrosis of the femoral head necrosis in MRI image (12 month) 3.The change of oxidative stress markers (4 weeks) 4.The change of flow mediated dilation(FMD)(4 weeks) | — |
Countries
Japan
Contacts
Public ContactSumiko Yoshida
Tokushima University Graduate School Department of Hematology, Endocrinology and Metabolism, Institute of Biomedical Sciences
Outcome results
None listed