UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008230 |
|---|---|
| Receipt number | R000009636 |
| Scientific Title | Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus |
| Date of disclosure of the study information | 2012/06/22 |
| Last modified on | 2014/09/24 14:03:21 |
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Basic information
Public title
Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus
Acronym
Control of steroid-induced osteonecrosis of the femoral head in SLE patients
Scientific Title
Clinical trial for the control of osteonecrosis of the femoral head secondary to the initial corticosteroid treatment in patients with systemic lupus erythematosus
Scientific Title:Acronym
Control of steroid-induced osteonecrosis of the femoral head in SLE patients
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of a concomitant administration of three drugs on the prevention of corticosteroid-induced osteonecrosis of the femoral head in patients with the initial corticosteroid treatment for systemic lupus erythematosus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of osteonecrosis of the femoral head on MR imaging of hip joints within six months after the initial corticosteroid treatment.
Key secondary outcomes
Safety of test drugs administration
Risk factors of osteonecrosisis of the femoral head
Symptomatic osteonecrosis at other than the femoral head
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
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).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Objectives must have been classified as systemic lupus erythematosus (SLE) based on the classification criteria of the American College of Rheumatology.
(2) Objectives need a systemic corticosteroid treatment of a dose of equal to or more than 0.5mg/kg/day (converted to prednisolone dose) for SLE.
(3) Objectives are hospitalized.
(4) Objectives are age of 20 or more.
(5) Objectives have consented to participate in the study after fully informed.
(6) Objectives that the laboratory data meets all the following.
i) Patients with more than 70,000/microL of platelets.
ii) Patients with less than 100IU/L of AST or ALT.
iii) Patients with more than 50ml/min of creatinine clearance.
Key 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.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihide Iwamoto |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5488
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuaki Yamamoto |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Orthopaedic Surgery
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5488
Homepage URL
yamataku@ortho.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Research Grant for Intractable Diseases from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新潟大学医歯学総合病院（新潟県）
埼玉医科大学総合医療センター（埼玉県）
慶應義塾大学病院（東京都）
順天堂大学医学部付属順天堂医院（東京都）
産業医科大学病院（福岡県）
九州大学病院（福岡県）
佐賀大学医学部付属病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 22 | Day |
Last modified on
| 2014 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009636
