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Osteoarthritis and Body Composition: Evaluation of Systematic Mediators

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771082
First Posted: October 10, 2008
Last Update Posted: June 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Aging (NIA)
  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 ]

Secondary Outcome Measures:
  • Changes in other biomarkers: inflammatory, metabolic, bone, and joint [ Time Frame: 3 to 5 years ]

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)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771082


Locations
United States, Maryland
National Institute on Aging
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Shari Ling, MD National Institute on Aging (NIA)