To Examine Whether or Not the Primary Causes of OA or RA Might be Bone Alterations

Sponsor

Shinshu University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02327650

Collaborator

(none)

200

Enrollment

Locations

109

Anticipated Duration (Months)

100

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Generally, osteoarthris (OA) is considered as primarily cartilage disease. However, as we and others have previously reported, a portion of OA might be caused primarily by bone alterations. In this study, we prospectively and retrospectively show that the bone altertations may affect OA primarily in all of the joints.

In addition, rheumatoid arthritis (RA) is a joint disease when immune system attacks synovium. Joint destruction occurrs continuously if suitable treatment is not performed. The etiology of RA is still largely unknown. As with OA, RA can be primarily damaged in bone, instead of cartilage. Here we prospectively and retrospectively show that the bone altertations may affect RA primarily in all of the joints.

Condition or Disease	Intervention/Treatment	Phase
Progression of Rheumatoid Arthritis Osteoarthritis of Multiple Joints	Procedure: The examinations for bones in joints of OA and RA patients

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The Examinations Whether or Not the Primary Causes of Osteoarthritis or Rheumatoid Arthritis in Joints Might be Bone Alterations

Actual Study Start Date :

Nov 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
RA and OA Every 2 or 3 months, plain radiograph, blood and urinary tests, and MRI are performed in the painful joints of RA.	Procedure: The examinations for bones in joints of OA and RA patients

Arm

Intervention/Treatment

RA and OA

Every 2 or 3 months, plain radiograph, blood and urinary tests, and MRI are performed in the painful joints of RA.

Procedure: The examinations for bones in joints of OA and RA patients

Outcome Measures

Primary Outcome Measures

The bone signal changes detected by MRI in OA and/or RA patients [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

RA and/or OA

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yukio Nakamura	Matsumoto	Nagano	Japan	3908621
2	Yukio Nakamura	Matsumoto		Japan

Sponsors and Collaborators

Shinshu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yukio Nakamura, Assistant Professor, Shinshu University

ClinicalTrials.gov Identifier:

NCT02327650

Other Study ID Numbers:

OA RA Bone Study

First Posted:

Dec 30, 2014

Last Update Posted:

Sep 21, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Osteoarthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Sep 21, 2021