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 2024/03/12 16:24:47

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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

Email

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


Email

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

Email

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

31

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

2024 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

2024 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030363


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name