UMIN-CTR Clinical Trial

Basic information
Public title	The effect of Lansoprazole in the prevention of osteonecrosis of the femoral head in patients with immune diseases treated corticosteroid
Acronym	The effect of Lansoprazole in the prevention of osteonecrosis of the femoral head in patients with immune diseases treated corticosteroid
Scientific Title	The effect of Lansoprazole in the prevention of osteonecrosis of the femoral head in patients with immune diseases treated corticosteroid
Scientific Title:Acronym	The effect of Lansoprazole in the prevention of osteonecrosis of the femoral head in patients with immune diseases treated corticosteroid
Region	Japan

Condition
Condition	non-traumatic osteonecrosis of the femoral head
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Prevention of non-traumatic osteonecrosis of the femoral head
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The effect of prevention efficacy of Lansoprazole using MRI at 3 and 6 months after corticosteroid treatment.
Key secondary outcomes

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	Takepron intravenous 30mg intravenously a total of 10 times (once the night before corticosteroid treatment started, and thereafter twice a day). Subsequently, Takepron OD 30mg orally once a day for 23 days.
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	18 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Primary orticosteroid dose of 35 mg/day or more.
Key exclusion criteria	Current ONFH; hip joint disease requiring surgery; alcohol-abuse; dementia; past allergy to LPZ; treatment with atazanavir sulfate.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ima Kosukegawa
Organization	Sapporo Medical University
Division name	Department of Orthopedic Surgery
Zip code
Address	S1W17, Chuo-ku, Sapporo, Hokkaido
TEL	+81116112111
Email	imakosukegawa@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Ima Kosukegawa
Organization	Sapporo Medical University
Division name	Department of Orthopedic Surgery
Zip code
Address	S1W17, Chuo-ku, Sapporo, Hokkaido
TEL	+81116112111
Homepage URL
Email	imakosukegawa@gmail.com

Sponsor
Institute	Sapporo Medical University hospital
Institute
Department

Funding Source
Organization	Department of Musculoskeletal Biomechanics and Surgical Development, Sapporo Medical University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 28 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	Terminated
Date of protocol fixation	2015 Year 05 Month 19 Day
Date of IRB	2015 Year 05 Month 19 Day
Anticipated trial start date	2015 Year 05 Month 19 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 28 Day
Last modified on	2019 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021788