Major clinical trial of osteoporosis screening begins
Posted on 12 December 2007
This [trial] is an exciting development for older women in the York and Hull areas
Professor David Torgerson
The seven-year trial will involve over 11,000 women in all, and is one of the largest studies of osteoporosis in the UK. Researchers from the York Trials Unit in the University’s Department of Health Sciences, with colleagues at universities in Birmingham, Bristol, Manchester, Sheffield and Southampton, are taking part in the project which is led by the University of East Anglia.
It has received funding of £4.13 million from the Medical Research Council (MRC) and the Arthritis Research Campaign (arc) and has the backing of the National Osteoporosis Society, whose president is the Duchess of Cornwall.
Osteoporosis leads to 200,000 fractures a year, 86,000 of which are debilitating hip fractures. These breaks not only adversely affect the lives of those who suffer them but cost health and social services about £1.7 billion a year.
Most people are only diagnosed with the condition and treated following a fracture. In some cases these fractures are life-threatening — around 20 per cent of those who suffer a hip fracture die within the year — so early diagnosis and prevention could have huge benefits.
A pilot study recently completed by the University of East Anglia and the University of Sheffield indicated that a systematic approach to screening older women for the disease could hold the key to early identification and treatment of those at high risk of a fracture.
Chief investigator Dr Lee Shepstone, of the University of East Anglia's School of Medicine, Health Policy and Practice, said: "Given the magnitude of the public health problem and the cost to the NHS of osteoporotic fractures, it makes sense to undertake an evaluation of community-based screening, followed by the offer of treatment to those considered at high risk of fracture. A widespread and systematic screening programme could prevent fractures, saving money and, more importantly, lives."
He added that it is particularly important to assess whether mass screening is cost-effective. "An appropriately designed screening programme might reduce the large direct cost to the NHS but at the same time incur the additional costs of detection and treatment."
Professor David Torgerson, Director of York Trials Unit, said: "Tackling osteoporosis is a major challenge for the NHS and the York Trials Unit will play a key role in evaluating the effectiveness of this screening programme. It is an exciting development for older women in the York and Hull areas."
The Department of Health recognises the importance of this research and has confirmed that the additional clinical costs of the study, such as the time GPs will spend on the project and the extra bone density scans, will be met through the UK Clinical Research Network (UKCRN).
The study, which begins in January 2008, will recruit women in the seven new centres. They will be divided into two groups. Those in the screening group will have their risk of fracture assessed through a combination of self-reported risk factors and, in some cases, a bone scan.
If appropriate, their GP may prescribe them a course of bisphosphonate drugs to combat bone thinning; recent studies suggest these drugs can reduce fracture risk by around 50 per cent. The control group will receive ‘usual care’. Both groups will be studied for five years and the number of fractures occurring in each will be compared.
Professor Alan Silman, medical director of the Arthritis Research Campaign, which funded the £200,000 18-month pilot study, said: "This is an area of huge public interest, and if the main trial backs up the results of the pilot study, it could lead to a big change in the way that older women with osteoporosis are identified and treated in future."
Claire Severgnini, chief executive of the National Osteoporosis Society, added: "The NOS is extremely pleased that research into osteoporosis is becoming prioritised. This study is likely to have a huge impact for those who have osteoporosis and for future generations."
Up to 15 GP practices in this area will be involved in the research, and will write to women aged between 70 and 85 over the coming months to ask them to take part in the ‘SCOOP’ study (Screening Of Older women for Prevention of fracture).
ENDS
Notes to editors:
- To arrange media interviews with the local study centre at University of York, contact David Garner, University Press Office, 01904 432153, dcg501@york.ac.uk.
- For further information or to arrange national media interviews contact Annie Ogden, UEA Press Office on 01603 592764, the Medical Research Council on 0207 637 6011 or the Arthritis Research Campaign on 01246 541107.
- The team, from the Universities of East Anglia, Bristol, Birmingham, Manchester, York, Sheffield and Southampton, has been awarded £3.75 million by the Medical Research Council, with additional funding of £380,000 from the Arthritis Research Campaign.
- The Medical Research Council is dedicated to improving human health through excellent science. It invests on behalf of the UK taxpayer and its work ranges from molecular level science to public health research, carried out in universities, hospitals, and a network of its own units and institutes.The MRC liaises with the health departments, the National Health Service and industry to take account of the public’s needs.The results have led to some of the most significant discoveries in medical science and benefited the health and wealth of millions of people in the UK and around the world. For more information visit www.mrc.ac.uk
- GP surgeries in each of the seven collaborating centres will be involved in recruiting around 1,600 women aged between 70 and 85-years-old (11,000 in total). Study participants will be asked to fill in a questionnaire and will be allocated at random to the screening or control group. Participants will be followed up for a minimum of five years to measure the fracture rate in both groups.
- The UK Clinical Research Network is working to develop and strengthen NHS infrastructure to support the delivery of clinical research in the UK. This is being achieved through the work of Clinical Research Networks which co-ordinate and support research in cancer, dementias and neurodegenerative diseases, diabetes, medicines for children, mental health, primary care and stroke.
Contact details
David Garner
University of York
01904 432153
Jill Beaumont
National Osteoporosis Society
01423 779662