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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001333
Receipt No. R000001619
Scientific Title MRI study of steroid-induced osteonecrosis
Date of disclosure of the study information 2008/08/22
Last modified on 2009/08/23

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Basic information
Public title MRI study of steroid-induced osteonecrosis
Acronym MRI study of steroid-induced osteonecrosis
Scientific Title MRI study of steroid-induced osteonecrosis
Scientific Title:Acronym MRI study of steroid-induced osteonecrosis
Region
Japan

Condition
Condition systemic lupus erythematosus and steroid-induced osteonecrosis
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Osteonecrosis is assocated with high-dose corticosteroid therapy and systemic lupus erythematosus (SLE). Early-stage osteonecrosis has been frequently misdiagnosed due to a lack of symptoms and changes observed with simple x-ray imaging. Currently, MRI is the gold standard for initial diagnosis of osteonecrosis. The frequency of steroid-induced osteonecrosis as observed with MRI is highest in the knee, followed by the hip, ankle, and shoulder joints, in that order. Thus MRI of bilateral hip and knee joints are effective as the screening examination of osteonecrosis.
SLE is one of the most frequent diseases underlying steroid-induced osteonecrosis, and its diagnostic criteria and treatment guidelines has been well established. We reported a prospective MRI study of SLE patients with 44 % of incidence of osteonecrosis at about three months after the initial steroid therapy. To our knowledge, however, long-term natural history of asymptomatic osteonecrosis has been unknown so far.
The purpose of this study was to clarify the long-term natural history of asymptomatic and non-collapsed osteonecrosis associated with corticosteroid therapy in SLE patients using MRI.
Basic objectives2 Others
Basic objectives -Others Observational study of epidemiology
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes of the necrotic area were evaluated as either improved, aggravated, or unchanged. Improvement was defined as either a reduction or disappearance of osteonecrosis, with reduction defined as an improvement of more than one type of the 2001 revised criteria for classification of osteonecrosis of the femoral head of the Japanese Ministry of Health, Labor and Welfare. Aggravation was defined as enlargement of a previous osteonecrotic lesion, a new lesion, and/or collapse of osteonecrosis. Enlargement included both cases that were enlarged after reduction of the necrotic area or were reduced after enlargement. Collapse was defined as MR finding of bone marrow edema with clinical symptom of pain. Collapse included cases subsequent to enlarged or new osteonecrotic lesions. Unchanged was defined as no change of the necrotic area.
A p-value less than 0.05 is considered significant using Fisher exact probability test.
Key secondary outcomes The total cumulative corticosteroid dose (g), mean corticosteroid dosage (mg/day), and duration of corticosteroid treatment (years) were compared between joints with and without osteonecrosis.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) The patients fulfill the 1982 revised criteria for the classification of SLE of American College of Rheumatology
(2)Asymptomatic joints at the initial examination
(3) MRI screening for osteonecrosis of all hip and knee joints
(4) Non-collapsed osteonecrosis at the initial MRI examination
(5) Periodic MRI examinations of all hip and knee joints
(6) Prospectively follow-up for at least 10 years
(7) Imformed consent about this study
(8) Outpatients
Key exclusion criteria (1) Previous trauma and surgery
(2) MRI can not undergo.
(3) Unfavorable patient condition
(4) Inappropriate patient
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name NAKAMURA JUNICHI
Organization Chiba University Hospital
Division name Orthopaedic Surgery
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba city
TEL 043-226-2117
Email

Public contact
Name of contact person
1st name
Middle name
Last name NAKAMURA JUNICHI
Organization Chiba University Hospital
Division name Orthopaedic Surgery
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba city
TEL
Homepage URL
Email shiken@office.chiba-u.jp

Sponsor
Institute Department of Orthopaedic Surgery, Graduate school of Medicine, Chiba University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2008 Year 08 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 Completed
Date of protocol fixation
2008 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 08 Month 01 Day
Date trial data considered complete
2009 Year 08 Month 01 Day
Date analysis concluded
2009 Year 08 Month 01 Day

Other
Other related information Influential factor: steroid
Outcome: necrotic area
Prospective study
Sampling of case control study

Management information
Registered date
2008 Year 08 Month 22 Day
Last modified on
2009 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001619

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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