UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026431 |
|---|---|
| Receipt number | R000030363 |
| Scientific Title | Analysis of molecular mechanism of systemic bone metabolism abnormality in systemic autoimmune diseases |
| Date of disclosure of the study information | 2017/03/07 |
| Last modified on | 2025/03/18 21:54:02 |
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Basic information
Public title
Analysis of molecular mechanism of systemic bone metabolism abnormality in systemic autoimmune diseases
Acronym
Analysis of molecular mechanism of systemic bone metabolism abnormality in systemic autoimmune diseases
Scientific Title
Analysis of molecular mechanism of systemic bone metabolism abnormality in systemic autoimmune diseases
Scientific Title:Acronym
Analysis of molecular mechanism of systemic bone metabolism abnormality in systemic autoimmune diseases
Region
| Japan |
Condition
Condition
Rheumatic disease
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to clarify the molecular mechanism of systemic bone metabolism abnormality in systemic autoimmune diseases.
Basic objectives2
Others
Basic objectives -Others
The purpose of the present study is also to reveal the differentiation-inducing factor of osteoclasts and osteoclast-like cells in the peripheral blood of patients with rheumatic diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of osteoclasts and osteoclast-like cells differentiated from peripheral blood mononuclear cells in rheumatic disease patients and healthy volunteers.
Key secondary outcomes
The differentiation-inducing factor of osteoclasts and osteoclast-like cells.
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
| Device,equipment |
Interventions/Control_1
Drawing blood twice from rheumatic disease patients
Interventions/Control_2
Drawing blood twice from healthy volunteers
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients and healthy volunteers at least 18 years old at enrollment
2) Patients diagnosed with rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, polymyositis, dermatomyositis, osteoarthritis) and healthy volunteers
3) Patients and healthy volunteers who have expressed their informed consent in writing
Key exclusion criteria
1) Patients and healthy volunteers who are more than 80 years old at enrollment
2) patients and healthy volunteers whom the investigator considers to be unsuitable for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yokota |
Organization
Saitama Medical University
Division name
Department of Rheumatology and Applied Immunology, Faculty of Medicine
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan
TEL
049-276-1462
yokotak@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yokota |
Organization
Saitama Medical University
Division name
Department of Rheumatology and Applied Immunology, Faculty of Medicine
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan
TEL
049-276-1462
Homepage URL
yokotak@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Institutional Review Board, Saitama Medical University
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan
Tel
049-276-1354
hirb@saitama-med.ac.jp
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
| 2017 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
35
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030363
