Major clinical trial of osteoporosis screening begins

Researchers are looking for local women in the Weston/North Somerset area over the age of 70 to take part in the second phase of a major clinical trial to find out if screening older women for osteoporosis can help to reduce the numbers who suffer bone fractures.

The seven-year trial will involve over 11,000 women in all and is one of the largest studies of osteoporosis in the UK. It is led by researchers from the University of East Anglia with Universities in Birmingham, Bristol, Manchester, York, Sheffield and Southampton also taking part. 

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 HRH 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, explained: "Osteoporosis is usually diagnosed using a DXA bone density scan, whose images allow the strength of bone to be assessed. At the moment, the people who are offered a scan are mainly those who have already suffered a fracture or are suspected by their GP to be at high risk.

"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."

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 that the arc are also pleased to be involved in the main part of the trial, adding: “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, said: “The NOS is extremely pleased to see that research into osteoporosis is becoming a priority.  This study is likely to have a huge impact for those who have osteoporosis and for future generations. We are delighted to offer our on-going support to this project.”

Dr Shane Clarke, Consultant Rheumatologist at Weston General Hospital, will co-ordinate the DXA scans for patients recruited by the research team at the University of Bristol. He says: "This prestigious MRC grant is tremendously important for our area. We have a relatively large elderly population and so osteoporosis is a major problem in our community. This study will help us diagnose patients we might not otherwise identify, and the treatment we can offer greatly reduce their chance of having a painful fracture in the future."

Dorothy Borbas, spokesperson for the local National Osteoporosis Society says "Weston-super-Mare Osteoporosis Support Group welcomes this long term study which should provide insight into the diagnosis, prevention and treatment of this debilitating disease. Apart from reducing health and social costs (estimated at £6 million annually in the Weston area) this study may well help to alleviate the considerable human suffering caused by fractured bones."

Approximately 15 GP practices in North Somerset 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). 

Dr Niamh Redmond, local study co-ordinator at the Academic Unit of Primary Health Care, University of Bristol says, “We are really excited to be involved in this large clinical trial alongside colleagues from six other Universities. We are looking forward to working with local GP practices and women in the North Somerset area to contribute to the success of this important study.”