NCT00595894

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,745

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

8 years

First QC Date

January 7, 2008

Last Update Submit

August 29, 2023

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisAfrican Americansosteopeniaosteoporosisbone mineral density

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and at 5 years disease

Study Arms (2)

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

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Clinical diagnosis of rheumatoid arthritis per ACR guidelines

You may not qualify if:

  • Patients with diagnosis \> 2yrs (CLEAR study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omaha Veteran's Affairs Medical Center

Omaha, Nebraska, 68105, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Baseline sera and DNA collected

MeSH Terms

Conditions

Arthritis, RheumatoidBone Diseases, MetabolicOsteoporosis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ted R Mikuls, MD, MSPH

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

July 1, 2004

Primary Completion

July 1, 2012

Study Completion

January 1, 2013

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(1)