UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020754 |
|---|---|
| Receipt number | R000023951 |
| Scientific Title | Investigation of clinical efficacy of pitavastatin against steroid-associated osteonecrosis of the femoral head |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2018/07/30 19:51:39 |
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Basic information
Public title
Investigation of clinical efficacy of pitavastatin against steroid-associated osteonecrosis of the femoral head
Acronym
Investigation of clinical efficacy of pitavastatin against steroid-associated osteonecrosis of the femoral head
Scientific Title
Investigation of clinical efficacy of pitavastatin against steroid-associated osteonecrosis of the femoral head
Scientific Title:Acronym
Investigation of clinical efficacy of pitavastatin against steroid-associated osteonecrosis of the femoral head
Region
| Japan |
Condition
Condition
steroid-associated osteonecrosis of the femoral head
Classification by specialty
| Medicine in general | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the preventive effect of pitavastatin against steroid-associated osteonecrosis of the femoral head for patients with high dose steroid therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administration of pitavastatin 2mg/day for patients with high LDL-cholesterol
Interventions/Control_2
no administration of pitavastat for patients without high LDL-cholesterol
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
| 85 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumiko Yoshida |
Organization
Tokushima University Graduate School
Division name
Department of Hematology, Endocrinology and Metabolism, Institute of Biomedical Sciences
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503 JAPAN
TEL
088-633-7120
yoshida.sumiko@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sumiko Yoshida |
Organization
Tokushima University Graduate School
Division name
Department of Hematology, Endocrinology and Metabolism, Institute of Biomedical Sciences
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima 770-8503 JAPAN
TEL
088-633-7120
Homepage URL
yoshida.sumiko@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Hematology, Endocrinology and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 27 | Day |
Last modified on
| 2018 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023951
