Osteoarthritis and Body Composition: Evaluation of Systematic Mediators

Knee Osteoarthritis Clinical Trial

Official title:

Osteoarthritis and Body Composition: Evaluation of Systematic Mediators

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00771082
• Other study ID #: AG0109
• Status: Terminated
• Phase: N/A
• First received: October 9, 2008
• Last updated: June 5, 2012
• Start date: January 2003
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1033
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
United States	National Institute on Aging	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in inflammatory marker c-reactive protein		3 to 5 years	No
Secondary	Changes in other biomarkers: inflammatory, metabolic, bone, and joint		3 to 5 years	No