Oral vitamin D 3 and calcium for secondary prevention of low-trauma fractures in elderly people ( Randomised Evaluation of Calcium Or vitamin D , RECORD ) : a randomised placebo-controlled trial
Introduction Low-trauma fractures in elderly people are a substantial and increasing burden of ill health, and those who have a low-trauma fracture are at high risk of another. Low serum concentrations of vitamin D metabolites are widespread in elderly people in the UK, especially in those with low-trauma fractures. Vitamin D and calcium, alone or in combination, are often recommended for prevention of osteoporotic fractures. Inadequate vitamin D status, exacerbated by low calcium intake, might raise the risk of these fractures by increasing bone resorption and loss from secondary hyperparathyroidism. Vitamin D might also protect against falls that lead to fracture. Evidence from randomised trials favours the combination of calcium and vitamin D. In this secondary-prevention study we aimed to test whether calcium and vitamin D, alone or in combination compared with placebo, would lead to one less person per 100 having a fracture every year over a median of 3 years. Methods Participants 15 024 people age 70 years or older who had had a lowtrauma, osteoporotic fracture in the previous 10 years were assessed between Feb 1, 1999, and March 31, 2002. The trial was based in 21 hospitals in the UK. Ethics approval was obtained from the Multicentre Research Ethics Committee for Scotland and from the local research ethics committee of each hospital, and participants gave written informed consent. Study nurses identified potential participants from hospital notes of patients seen in a fracture clinic or orthopaedic ward; patients were also recruited by telephone. Reasons for exclusion were: bed or chair bound before fracture; cognitive impairment indicated by an abbreviated mental test score of less than seven; cancer in the past 10 years that was likely to metastasise to bone; fracture associated with pre-existing local bone abnormality; those known to have hypercalcaemia; renal stone in the past 10 years; life expectancy of less than Published online April 28, 2005 DOI: 10.1016/S0140-6736(05) 63013-9