Osteoarthritis and Body Composition: Evaluation of Systematic Mediators

NCT ID: NCT00771082

Last Updated: 2012-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1033 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Responsible Party

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National Institute on Aging

Principal Investigators

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Shari Ling, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute on Aging (NIA)

Locations

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National Institute on Aging

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9704632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7783067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8923372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10627432 (View on PubMed)

Other Identifiers

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AG0109

Identifier Type: -

Identifier Source: org_study_id

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