ArticlesOral vitamin D3 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,1, 2 and those who have a low-trauma fracture are at high risk of another.3 Low serum concentrations of vitamin D metabolites are widespread in elderly people in the UK,4 especially in those with low-trauma fractures.5 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.6 Evidence from randomised trials favours the combination of calcium and vitamin D.7 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.
Section snippets
Participants
15 024 people age 70 years or older who had had a low-trauma, 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
Results
Figure 1 shows the trial profile. Of 15 024 people assessed, about a third joined the trial and about 3500 of those who were eligible did not participate. Those recruited were younger (mean age 77 years [SD 6]) than were those who declined (80 years [6]) or who were ineligible (82 years [7]). The main reasons for ineligibility were cognitive impairment (2666 [43·0%]), current antiosteoporotic treatment (2103 [33·9%]), and previous excluding cancer (680 [11·0%]); this group also had a higher
Discussion
In this trial of secondary-fracture prevention, incidence of fractures did not differ between those allocated any calcium versus no calcium, between those allocated any vitamin D3 versus no vitamin D3, or between those allocated combination treatment versus placebo.
As expected, the rate of further low-trauma fracture was high (one in eight). However, there were fewer hip fractures than anticipated, which was related to the tendency for older people to be ineligible because of cognitive
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