Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ted Mikuls, MD MSPH, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00595894
First received: January 7, 2008
Last updated: June 18, 2013
Last verified: March 2011
  Purpose

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


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: RA Comorbidity: Bone Health in Men and African Americans

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: baseline and at 5 years disease ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Baseline sera and DNA collected


Enrollment: 1745
Study Start Date: July 2004
Study Completion Date: January 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: January 7, 2008
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 22, 2014