Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans

NCT ID: NCT00595894

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1745 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-07-01

Study Completion Date

2013-01-01

Brief Summary

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The objective of the proposed study is to assess bone health and determinants of bone health among select subpopulations of rheumatoid arthritis patients.

Detailed Description

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The overall hypothesis of this study is that osteopenia and/or osteoporosis are common among African Americans and men with rheumatoid arthritis and there are identifiable genetic and environmental factors contributing to the pathogenesis of bone loss in these groups.

The Specific Aims of the study are to:

1. Determine baseline hip and lumbar spine bone density (BMD) values and osteopenia/osteoporosis prevalence among African American men and women with early RA and among male veterans with established RA.
2. Identify environmental factors and candidate alleles, which confer increased risk of reduced baseline BMD loss over time among African American men and women with early RA and among male veterans with established RA.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 CLEAR participants - African Americans with early rheumatoid arthritis

CLEAR enrollees include African American patients with early rheumatoid arthritis, as defined using ACR criteria

No interventions assigned to this group

2 VARA participants - male veterans with established rheumatoid arthritis

VARA enrollees will include male veterans with established RA diagnosed using ACR criteria

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of rheumatoid arthritis per ACR guidelines

Exclusion Criteria

* Patients with diagnosis \> 2yrs (CLEAR study)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ted R Mikuls, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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Omaha Veteran's Affairs Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Related Links

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http://www.nih.gov

National Institute of Health

Other Identifiers

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5K23AR050004-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0028-03-ET

Identifier Type: -

Identifier Source: org_study_id

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