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NCT00595894 Clinical Trial

Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans

Rheumatoid Arthritis Clinical Trial

Official title:
RA Comorbidity: Bone Health in Men and African Americans

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00595894
Other study ID # 0028-03-ET
Secondary ID 5K23AR050004-04
Status Completed
Phase
First received
Last updated
Start date July 1, 2004
Est. completion date January 1, 2013

Study information
Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 1745
Est. completion date January 1, 2013
Est. primary completion date July 1, 2012
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Clinical diagnosis of rheumatoid arthritis per ACR guidelines Exclusion Criteria: - Patients with diagnosis > 2yrs (CLEAR study)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Omaha Veteran's Affairs Medical Center Omaha Nebraska

Sponsors (2)
Lead Sponsor Collaborator
University of Nebraska National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone mineral density Bone mineral density (BMD) test measures calcium and other minerals in bone. Bones containing more minerals are denser, so they tend to be stronger and less likely to break. baseline and at 5 years disease
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