To Examine Whether or Not the Primary Causes of OA or RA... | NCT02327650

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

NCT02327650

Sponsor

Shinshu University

Status

Unknown status

Last Update Posted

Sep 21, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Progression of Rheumatoid Arthritis
Osteoarthritis of Multiple Joints

Interventions

The examinations for bones in joints of OA and RA patients

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Apr 2022Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Dec 21, 2014

First Submission Date that Met QC Criteria

Dec 24, 2014

First Posted Date

Dec 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The examinations for bones in joints of OA and RA patients	Procedure		RA and OA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The bone signal changes detected by MRI in OA and/or RA patients		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

RA and/or OA

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The patients who have OA with accompaying joint pain or the patients who have RA with accompaying joint pain

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yukio Nakamura	Recruiting	Matsumoto	Nagano	3908621	Japan