Nottingham Osteoarthritis Biomarker Study 2011

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. Identifier: NCT01495455
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:

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 or disease

Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Nottingham Osteoarthritis Biomarker Study 2011
Study Start Date : February 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Knee osteoarthritis
No knee pain/osteoarthritis

Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Serum, urine and synovial fluid.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
- Secondary care clinics

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

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 identifier (NCT number): NCT01495455

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

Responsible Party: University of Nottingham Identifier: NCT01495455     History of Changes
Other Study ID Numbers: 11049
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases