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Completed

NCT Number: NCT00595894

Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Bone Diseases, Metabolic Connective Tissue Diseases Immune System Diseases Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Omaha Veteran's Affairs Medical Center

Omaha, Nebraska, 68105, United States

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of rheumatoid arthritis per ACR guidelines

Exclusion criteria

  • Patients with diagnosis > 2yrs (CLEAR study)

Treatment and study plan

Primary outcomes

  1. Bone mineral density

    Time frame: baseline and at 5 years disease

    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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

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

Registry information

Official study title

RA Comorbidity: Bone Health in Men and African Americans

Important dates

Study start
2004
Primary completion
2012
Study completion
2013
First posted
Jan 16, 2008
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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