Osteoarthritis and Body Composition: Evaluation of Systematic Mediators

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00771082

Enrollment

1033

Registered

2008-10-10

Start date

2003-01-31

Completion date

2012-12-31

Last updated

2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

inflammatory markers, bone markers, OA

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Changes in inflammatory marker c-reactive protein	3 to 5 years

Secondary

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

Countries

United States

Outcome results