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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020754
Receipt No. 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

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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
Email 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
Email yoshida.sumiko@tokushima-u.ac.jp

Sponsor
Institute Department of Hematology, Endocrinology and Metabolism, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023951

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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