Osteoarthritis and Body Composition: Evaluation of Systematic Mediators
This study has been terminated.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00771082
First received: October 9, 2008
Last updated: June 5, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to examine the relationship between body composition and knee osteoarthritis, and effects of inflammatory, metabolic, and hormonal factors.
| Condition |
|---|
|
Knee Osteoarthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Osteoarthritis and Body Composition: Evaluation of Systematic Mediators |
Resource links provided by NLM:
Further study details as provided by National Institute on Aging (NIA):
Primary Outcome Measures:
- Changes in inflammatory marker c-reactive protein [ Time Frame: 3 to 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in other biomarkers: inflammatory, metabolic, bone, and joint [ Time Frame: 3 to 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Banked serum and urine samples
| Enrollment: | 1033 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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:
- 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.
- 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| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Baltimore Longitudinal Study on Aging
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
Contacts and Locations More Information
Publications:
| Responsible Party: | Shari Ling, MD, National Institute on Aging |
| ClinicalTrials.gov Identifier: | NCT00771082 History of Changes |
| Other Study ID Numbers: | AG0109 |
| Study First Received: | October 9, 2008 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Aging (NIA):
|
inflammatory markers bone markers OA |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013