DISKO

Trial Name: The Effect of a Subcutaneous Injection of Denosumab on Pain and Bone Marrow Lesions in Men and Women with Symptomatic Knee Osteoarthritis : A Randomised Double Blind Placebo Controlled Clinical Trial

Chief Investigator: Professor Terence O’Neill

Trial Description: A Phase III, randomised, double blind, placebo controlled trial

Background: Knee osteoarthritis is associated with substantial pain and disability. Evidence suggests bone marrow lesions are an important source of knee pain and act as an indicator of disease progression. Denosumab, a potent anti resorptive, is being trialled as a targeted therapy, proposed to reduce pain and specifically reduce bone marrow lesions through structural modification.

Main Outcomes: To determine the effect of a single, subcutaneous dose of Denosumab on knee pain and total bone marrow lesion area.

Patients to be recruited: 167

Status: Live

CTU: Manchester Academic Health Science Centre Trials Co-ordination Unit

ISRCTN Number: 96920058

Funder: Arthritis Research UK

Further Information: Trial Manager Michelle Tetlow: Michelle.Tetlow@manchester.ac.uk

Trial Website: www.manchester.ac.uk/roam