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Nottingham Osteoarthritis Biomarker Study 2011

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01495455
First received: November 30, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

Osteoarthritis is by far the most common joint condition and the single largest cause of disability in the older population. The investigators still have a poor understanding of the nature of osteoarthritis and factors that influence its development and progression. Identification of biochemical markers that relate to cartilage loss, bony overgrowth and other features that occur with osteoarthritis will advance our understanding. Over the last 5 years analytical methods have developed to measure a range of different biomarkers. This pilot study will use these analytical methods to measure biomarker levels in joint fluid, urine and blood of 50 participants with Osteoarthritis (OA) and 50 healthy volunteers.

This study will provide novel pilot data on the changes in the composition of the synovial fluid, urine and blood in patients with OA. Apart from being a key target site for OA, the knee is a suitable joint for study because of its accessibility to clinical assessment, joint aspiration and imaging.


Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Nottingham Osteoarthritis Biomarker Study 2011

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Difference in the levels of pro-inflammatory and anti-inflammatory lipids mediators between individuals with knee osteoarthritis and those with normal knees. [ Time Frame: within 6 months of recruitment of last participant ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, urine and synovial fluid.


Enrollment: 140
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Knee osteoarthritis
No knee pain/osteoarthritis

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

- Secondary care clinics

Criteria

Inclusion Criteria:

All participants:

  • Be able to provide written informed consent
  • Aged 30 and over

Knee OA patients:

• Radiographic signs of OA - that is definite joint space narrowing plus osteophyte in at least one compartment of the knee

Normal controls:

  • No knee pain
  • No clinical or radiographic changes of knee OA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495455

Locations
United Kingdom
Academic Rheumatology, University of Nottingham
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Michael Doherty, MA MB FRCP University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01495455     History of Changes
Other Study ID Numbers: 11049
Study First Received: November 30, 2011
Last Updated: January 29, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013