New clinical trial to test effectiveness of systematic screening for osteoporosis in older women
Up to 800 women over the age of 70 are to take part in the first phase of a major new clinical trial to find out if screening for osteoporosis in older women can help to reduce the number of fractures.
Osteoporosis, a thinning of the bones particularly affecting women, leads to more than 200,000 fractures every year. Around half of people who suffer a hip fracture are no longer able to look after themselves, and 20 per cent die within a year.
Fractures are a huge drain on the nation's resources, with the 86,000 hip fractures suffered each year costing the health and social services around £1.7bn.
The trial, funded by the Arthritis Research Campaign, will also aim to establish if screening of older women makes economic sense. The trial team, a collaboration between the Universities of East Anglia and Sheffield, want to find out how much screening would cost, as well as how effective it would be in reducing the number of fractures occurring each year.
Osteoporosis is diagnosed using a bone scan, called dual-energy x-ray absorptiometry, or DXA. The images produced allow the strength of the bone to be assessed.
At the moment, however, there is no standard screening tool that is used to check for the risk of fracture, according to the leader of the arc clinical trial, Dr Lee Shepstone, Reader in Medical Statistics at the University of East Anglia's school of Medicine, Health Policy and Practice.
"It's very ad hoc at the moment; the people who are offered a DXA scan to check for osteoporosis are often those who have already suffered a fracture, or are suspected to be at high risk by their GP, for example, because they have been on steroids for a long time," he said.
"Given the magnitude of the public health problem posed by osteoporotic fractures – in particular hip fractures – and the existence of effective screening techniques and treatment – it makes sense to undertake a community-based evaluation of screening - followed by the offer of treatment to those at high risk of fracture."
Although osteoporosis is more common in women after the menopause, the risk of fracture rises sharply after the age of around 70.
GP surgeries in Norfolk and Sheffield will be involved in recruiting the 800 women aged 70 and over. Patients taking part will be asked to fill in a questionnaire. The women will be randomly split into two groups, a screening arm and a "control" arm.
Those in the screening group will have their risk of fracture assessed through a combination of self-reported risk factors and information from the DXA bone scan, either at the Norfolk and Norwich Hospital or the Northern General Hospital in Sheffield.
Based upon this information, their GPs may be recommended to start a course of treatment of bisphosphonate drugs which combat bone thinning. Those in the control group will be given what is called "usual care" which means treatment after a fracture has occurred, of if the GP has an increased concern about fracture.
The research will be undertaken by a multidisciplinary team consisting of GPS, rheumatologists, public health specialists, economists and statisticians. The team consider that there is compelling evidence that bisphosphonates can successfully decrease the incidence of osteoporotic fractures. Recent studies of bisphosphonates in osteoporotic women suggest an estimated reduction in fracture risk of around 50 per cent.
"Finding out if mass screening is cost-effective is also of central importance, and we will focus on the direct costs to the NHS, since the majority of current costs of osteoporotic fractures fall on the health care system, " added Dr Shepstone. "An appropriately designed screening programme might reduce these costs, but at the same time incur the additional costs of detection and treatment."
The team currently have arc funding of £200,000 to finance an 18-month feasibility study involving up to 800 patients. If recruitment levels can be reached and screening and treatment take-up rates are adequate, then further funding of £380,000 will be awarded for a larger study involving thousands of women at the two sites. Recruitment is likely to start in July and August this year.
For more information email info@arc.org.uk
