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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000008230 |
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Date of registration:
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22/06/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus
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Scientific title:
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Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus - Control of steroid-induced osteonecrosis of the femoral head in SLE patients |
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Date of first enrolment:
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2014/08/01 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009636 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yukihide Iwamoto |
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Address:
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3-1-1 Maidashi, Higashi-ku, Fukuoka
Japan |
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Telephone:
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092-642-5488 |
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Email:
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Affiliation:
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Graduate School of Medical Sciences, Kyushu University Department of Orthopaedic Surgery |
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Name:
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Takuaki Yamamoto |
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Address:
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3-1-1 Maidashi, Higashi-ku, Fukuoka
Japan |
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Telephone:
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092-642-5488 |
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Email:
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yamataku@ortho.med.kyushu-u.ac.jp |
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Affiliation:
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Graduate School of Medical Sciences, Kyushu University Department of Orthopaedic Surgery |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: A. Objectives have never had corticosteroid treatment before the entry to the trial. B. Objectives have never been affected with osteonecrosis of the femoral head. C. Patients with any active bleeding lesion. D. Patients with any active infection. E. Patients have any contraindication to candidate drugs for the prevention. F. Patients have any past histories of anaphylaxis to candidate drugs for the prevention. G. Female in pregnancy, lactation period, having a possibility of pregnancy. H. Patients taking below contraindicative drugs. 1. antiplatelet drugs expect clopidogrel 2. anticoagulant 3. cyclosporine 4. fibrates I. Patients that have contraindication for MRI. J. Patients that are considered unsuitable for the entry to the trial.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Systemic lupus erythematosus
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Intervention(s)
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Objectives take three below candidate drugs for the prevention for at least 3 months after the initial corticosteroid treatment. 1. Clopidgrel Bisulfate (Plavix) Taking a dose of 300mg once daily on the first day, and a dose of 75mg once daily on subsequent days. 2. Pitavastatin Calcium (LIVALO) Taking a dose of 2mg once daily. 3. Tocopherol Acetate (Juvela) Taking a dose of 100mg three times daily (total of 300mg daily).
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Primary Outcome(s)
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Incidence of osteonecrosis of the femoral head on MR imaging of hip joints within six months after the initial corticosteroid treatment.
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Secondary Outcome(s)
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Safety of test drugs administration Risk factors of osteonecrosisis of the femoral head Symptomatic osteonecrosis at other than the femoral head
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Source(s) of Monetary Support
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Research Grant for Intractable Diseases from the Ministry of Health, Labour and Welfare of Japan
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/08/2016 |
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URL:
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