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
  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)
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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771082

Locations
United States, Maryland
National Institute on Aging
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Investigators
Principal Investigator: Shari Ling, MD National Institute on Aging (NIA)
  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 April 17, 2014