UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001333 |
|---|---|
| Receipt number | 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 22:24:03 |
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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
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
shiken@office.chiba-u.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Graduate school of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001619
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