Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans

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

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

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

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.


Inclusion Criteria:

  • Clinical diagnosis of rheumatoid arthritis per ACR guidelines

Exclusion Criteria:

  • Patients with diagnosis > 2yrs (CLEAR study)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00595894

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
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 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
bone mineral density

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on March 01, 2015