Rheumatoid ArthritisNCT00595894
Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans
An observational study of Rheumatoid Arthritis, run by University of Nebraska at 1 site in United States.
Trial summary
The objective of the proposed study is to assess bone health and determinants of bone health among select subpopulations of rheumatoid arthritis patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 1,745 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2004to 1 Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of rheumatoid arthritis per ACR guidelines
Who cannot join
- Patients with diagnosis > 2yrs (CLEAR study)
Trial locations and contacts
1 site in 1 country.
United States1 site
Omaha Veteran's Affairs Medical Center
Omaha, Nebraska, 68105
About this study
Official title: RA 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, African Americans, osteopenia, osteoporosis, bone mineral density
- Medical subject headings
- Arthritis, Rheumatoid, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 CLEAR participants - African Americans with early rheumatoid arthritis | CLEAR enrollees include African American patients with early rheumatoid arthritis, as defined using ACR criteria | |
| 2 VARA participants - male veterans with established rheumatoid arthritis | VARA enrollees will include male veterans with established RA diagnosed using ACR criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
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.
Measured: baseline and at 5 years disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study start1 Jul 2004
- Primary completion1 Jul 2012
- Study completion1 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,745 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Ted R Mikuls, MD, MSPH, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595894
- Sponsor's protocol ID
- 0028-03-ET
- Other IDs
- 5K23AR050004-04
- Status last verified
- Aug 2023
- First submitted
- 7 Jan 2008
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RA Comorbidity: Bone Health in Men and African Americans
- ClinicalTrials.gov ID
- NCT00595894
- Acronym / sponsor ID
- 0028-03-ET
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, African Americans, osteopenia, osteoporosis, bone mineral density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,745 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jul 2004 (actual)
- Primary completion
- 1 Jul 2012 (actual)
- Study completion
- 1 Jan 2013 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the proposed study is to assess bone health and determinants of bone health among select subpopulations of rheumatoid arthritis patients.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 CLEAR participants - African Americans with early rheumatoid arthritis | – | –CLEAR enrollees include African American patients with early rheumatoid arthritis, as defined using ACR criteria |
| 2 VARA participants - male veterans with established rheumatoid arthritis | – | –VARA enrollees will include male veterans with established RA diagnosed using ACR criteria |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical diagnosis of rheumatoid arthritis per ACR guidelines
Key exclusion criteria (1 listed)
- Patients with diagnosis > 2yrs (CLEAR study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- National Institute of HealthLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted R Mikuls, MD, MSPH principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: baseline and at 5 years disease). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.