Osteoporotic fractures, in particular hip fractures present a considerable burden to the National Health Service and to the individual. Around 50% of hip fracture patients lose the ability to live independently and 20% die within a year of their fracture.
The SCOOP study, following on from an 18 month feasibility study, is a UK 7 centre, unblinded, pragmatic, randomised controlled trial lasting 87 months with a minimum of 5 years follow-up. A total of 11 580 women, aged 70 to 85 and not currently on prescription medication to prevent osteoporotic fractures, will be consented into the trial by post via primary care.
Upon receipt of valid baseline data, participants will be randomised to either a screening arm or control arm. Those in the screening arm will have a 10-year fracture probability computed from baseline risk factors together with bone mineral density measured via a DXA scan in selected subjects. Individuals above an age-dependent threshold will be recommended for treatment (typically an oral bisphosphonate) to continue treatment for the duration of the trial.
Study participants are followed-up at 6 months after randomisation and annually by postal questionnaires and checking of hospital radiology and admissions records plus primary care sources. The primary outcome measure will be the proportion of individuals sustaining fractures in each group; hip fracture rate will be a secondary outcome measure. An economic analysis will be carried out to assess cost-effectiveness.