UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of clinical efficacy of pitavastatin against steroid-associated osteonecrosis of the femoral head
Title of the study (Brief title)	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	Sumiko Yoshida
Organization	Tokushima University Graduate School
Division name	Department of Hematology, Endocrinology and Metabolism, Institute of Biomedical Sciences
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	Sumiko Yoshida
Organization	Tokushima University Graduate School
Division name	Department of Hematology, Endocrinology and Metabolism, Institute of Biomedical Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023951