Ensayo controlado aleatorio de los suplementos de calcio y vitamina D para la prevención de fracturas en la atención primaria

Fall related low-trauma fractures represent a significant burden of illness in older people. One relatively inexpensive method of reducing fracture rates might be through the use of calcium and vitamin D supplementation. The objective of this study was to assess whethe¡ calcium and vitamin D supplementation givel to women ased 70 years and over at increased lisk prevents fractures. Pragmatic 'open' randomised controlled trial ol nurse led clinics in primary care. Those randomised to the intervention group received daily oral supplementation of 1000 mg of calcium with 800 IU vitamin D3 with a patient information leaflet on dietary calcium intake and falls prevention. The control group received just the leaflet. The main outcome measure was all clinical fractures Secondary outcome measures were treatment adherence, falls and quality of life (as measured by the SF12). We recruited and randomised 3322 women aged 70 years and over who had at least one risk factor for hip fracture. Of those completing the 24 month follow-up questionnaire 69% were still taking supplements including all randomised participants, known to be alive. this was 55%. After a median follow-up of 25 months (range l8 to 42 months) there were no significant differences in all clinical fractures. The odds ratio (OR) for fracture in the supplementation group was 1.03 compared with the unsupplemented group (95% confidence interval, 0.74 to 1.43. p = 0.86). For hip fracture the OR was 0.82 (0.37 to 1.82, p = 0.63) Giving women who have one or more risk factors for hip fracture calcium and vitamin D supplements does not reduce their risk of sustaining a clinical fracture.