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Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans

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ClinicalTrials.gov Identifier: NCT00595894
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Rheumatoid Arthritis

Detailed 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.

Study Design

Study Type : Observational
Actual Enrollment : 1745 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RA Comorbidity: Bone Health in Men and African Americans
Study Start Date : July 2004
Primary Completion Date : July 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
CLEAR enrollees include African American patients with early rheumatoid arthritis, as defined using ACR criteria
2
VARA enrollees will include male veterans with established RA diagnosed using ACR criteria


Outcome Measures

Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: baseline and at 5 years disease ]

Biospecimen Retention:   Samples With DNA
Baseline sera and DNA collected

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CLEAR enroll African American RA patients from 4 core academic centers in the Southeast U.S. VARA enroll RA patientss from participating VA medical centers.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of rheumatoid arthritis per ACR guidelines

Exclusion Criteria:

  • Patients with diagnosis > 2yrs (CLEAR study)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595894


Locations
United States, Nebraska
Omaha VA Medical Center
Omaha, Nebraska, United States, 68105
Omaha Veterans Affairs Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Ted R Mikuls, MD, MSPH University of Nebraska
More Information

Additional Information:
Responsible Party: Ted Mikuls, MD MSPH, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00595894     History of Changes
Other Study ID Numbers: 028-03-ET
5K23AR050004-04 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: March 2011

Keywords provided by Ted Mikuls, MD MSPH, University of Nebraska:
rheumatoid arthritis
African Americans
osteopenia
osteoporosis
bone mineral density

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases