Extrait

Background and study aims Osteoporosis is a condition that weakens the bones, making them fragile and more likely to break (fracture). Osteoporotic fractures – in particular hip fractures – have major adverse effects on quality of life in terms of pain and disability. Around 50% of hip fracture patients lose the ability to live independently and 20% die within a year of their fracture. The aim of this study is to investigate whether a community-based screening programme for osteoporosis reduces the incidence of fractures, and is cost effective, in older women (aged 70 - 85 years). Who can participate? Women aged 70 to 85 who are not currently on prescription medication to prevent osteoporotic fractures. What does the study involve? Participants are randomly allocated to either the screening group or the control group. Those in the screening group have their risk of fracture calculated using data from a questionnaire and, for some participants, results from a DXA (x-ray) scan. Participants above an age-dependent threshold are recommended for treatment (typically bisphosphonate tablets), and to continue treatment for the duration of the study. The risk of fracture is not calculated for participants in the control group, who receive usual care. Participants are followed-up 6 months later and then annually by postal questionnaires and checking of medical records. The proportion of participants sustaining fractures is measured for each group, along with hip fracture rate. Cost-effectiveness is also assessed, as well as the acceptability of the DXA scanning and risk assessment process. What are the possible benefits and risks of participating? Participants in the screening group have the opportunity to discuss treatment with their GP that would reduce their fracture risk. In addition, everyone taking part in the study will be helping to determine whether screening would be beneficial in older women. Taking part in this study will involve some time to complete questionnaires. If a participant in the screening group is invited to have a DXA bone density scan this would involve a single appointment lasting about 15 to 30 minutes with the DXA provider (usually at an NHS hospital trust). The DXA scanner uses much less radiation than a normal x-ray, such as a chest x-ray, and is equivalent to a few days of natural background radiation. Where is the study run from? University of East Anglia (UK) When is the study starting and how long is it expected to run for? February 2007 to December 2015 Who is funding the study? 1. Medical Research Council (MRC) (UK) 2. Arthritis Research Campaign (UK) Who is the main contact? Prof. Lee Shepstone [email protected]

Critère d'inclusion

• Musculoskeletal Diseases: Osteoporosis

Liens

• ictrp
• isrctn