Clinical trial NCT00771082: Osteoarthritis and Body Composition: Evaluation of Systematic Mediators
Official title: Osteoarthritis and Body Composition: Evaluation of Systematic Mediators
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Keywords: inflammatory markers
bone markers
OA
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2008-10-10
Enrollment: 1033
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Baltimore Longitudinal Study on Aging

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in inflammatory marker c-reactive protein
timeFrame: 3 to 5 years
Secondary outcomes:
measure: Changes in other biomarkers: inflammatory, metabolic, bone, and joint
timeFrame: 3 to 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute on Aging
state: Maryland
Study officials:
affiliation: National Institute on Aging (NIA)
name: Shari Ling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Felson DT, Zhang Y. An update on the epidemiology of knee and hip osteoarthritis with a view to prevention. Arthritis Rheum. 1998 Aug;41(8):1343-55. doi: 10.1002/1529-0131(199808)41:83.0.CO;2-9. No abstract available.
citation: Hochberg MC, Lethbridge-Cejku M, Scott WW Jr, Reichle R, Plato CC, Tobin JD. The association of body weight, body fatness and body fat distribution with osteoarthritis of the knee: data from the Baltimore Longitudinal Study of Aging. J Rheumatol. 1995 Mar;22(3):488-93.
citation: Lethbridge-Cejku M, Tobin JD, Scott WW Jr, Reichle R, Roy TA, Plato CC, Hochberg MC. Axial and hip bone mineral density and radiographic changes of osteoarthritis of the knee: data from the Baltimore Longitudinal Study of Aging. J Rheumatol. 1996 Nov;23(11):1943-7.
citation: Sharif M, Shepstone L, Elson CJ, Dieppe PA, Kirwan JR. Increased serum C reactive protein may reflect events that precede radiographic progression in osteoarthritis of the knee. Ann Rheum Dis. 2000 Jan;59(1):71-4. doi: 10.1136/ard.59.1.71.