A clinical trial of denosumab in patients with knee osteoarthritis

Disease - Osteoarthritis, knee pain

Lead applicant - Professor Terence O'Neill

Organisation - University of Manchester

Type of grant - Clinical Studies

Status of grant - Active

Amount of the original award - £708,264.70

Start date - 4 January 2016

Reference - 20829

Public Summary

What are the aims of this research?

At present, there are no treatments for knee osteoarthritis (OA) which both reduce pain and slow disease progression. Many patients with knee OA have abnormalities in their bone marrow, the flexible tissue inside bones, which are visible using advanced imaging and are thought to be a source of pain. This research study aims to determine whether denosumab, a drug used in the treatment of osteoporosis, can reduce the severity of knee pain and bone marrow changes in patients with OA.

Why is this research important?

Current treatments for OA can be difficult to take, may cause side effects and are not very effective in some patients. Denosumab is already available on the NHS for osteoporosis, so if it is found to be beneficial for OA then it is likely to be made available for OA patients much quicker than if it were a completely new drug.

166 patients aged 50 years and over with painful knee OA will receive either an injection of denosumab or a placebo injection which should have no effect to allow comparison. Their knee pain will be assessed and imaging of their affected knee carried out to look for bone marrow changes at the beginning of the study and again after 6 months.

How will the findings benefit patients?

There is a need for new treatments for osteoarthritis which can reverse some of the changes caused by the disease and to relieve pain in a more effective way. If denosumab is found to be beneficial, it will offer real hope for development of a new approach to treatment in patients with painful knee OA.