Osteoarthritis and Body Composition: Evaluation of Systematic Mediators

Terminated

• Conditions: Knee Osteoarthritis

• Registration Number: NCT00771082
• Lead Sponsor: National Institute on Aging (NIA)

Brief Summary

The purpose of this study is to examine the relationship between body composition and knee osteoarthritis, and effects of inflammatory, metabolic, and hormonal factors.

Detailed Description

Banked serum and urine specimens obtained from NIA Baltimore Longitudinal Study on Aging (BLSA) participants with and without knee OA will be used to determine inflammatory, metabolic, bone and joint biomarkers in an observational, case-control study. This study will be limited to BLSA data and samples that have already been acquired and stored.

The specific aims of this study are to:

1. Examine the association between prevalent radiographic osteoarthritis (OA), concurrently obtained inflammatory and metabolic mediator levels and change in bone density and bone markers over time subsequent to radiographic classification.

2. Determine levels of inflammatory, metabolic and bone markers, and body composition when radiographic OA was absent, and examine their relationship to the development of radiographic knee OA.

Adjustments will be made for age, gender, body mass index and level of physical activity.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1033

Inclusion Criteria

• Participants of the BLSA who have had 1 or more DXA scans AND who were either classified as having radiographic knee OA (Kellgren & Lawrence 2 or higher) or as having no radiographic knee OA on two or more xrays (KL 0-1)

Exclusion Criteria

• Diagnosis of rheumatoid arthritis
• Diagnosis of malignancy
• Reported use of prednisone and other immunosuppressive medications or insulin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in inflammatory marker c-reactive protein	3 to 5 years

Secondary Outcome Measures

Name	Time	Method
Changes in other biomarkers: inflammatory, metabolic, bone, and joint	3 to 5 years

Trial Locations

Locations (1)

National Institute on Aging; 🇺🇸 Baltimore, Maryland, United States