Trial record 6 of 147 for:
Open Studies | "African Americans"
Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Nebraska.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Nebraska
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00595894
First received: January 7, 2008
Last updated: March 1, 2011
Last verified: March 2011
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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
| Estimated Enrollment: | 3600 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (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:
- 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595894
Contacts
| Contact: Ted R Mikuls, MD, MSPH | 402-559-7258 | tmikuls@unmc.edu |
Locations
| United States, Nebraska | |
| Omaha VA Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68105 | |
| Contact: Ted R Mikuls, MD, MSPH 402-559-7258 tmikuls@unmc.edu | |
| Omaha Veterans Affairs Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68105 | |
| Contact: Ted R Mikuls, MD, MSPH 402-559-8846 tmikuls@unmc.edu | |
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, University of Nebraska Medical Center |
| ClinicalTrials.gov Identifier: | NCT00595894 History of Changes |
| Other Study ID Numbers: | 028-03-ET, 5K23AR050004-04 |
| Study First Received: | January 7, 2008 |
| Last Updated: | March 1, 2011 |
| 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 May 23, 2013