Oral 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
Oral 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
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DOI：
10.1016/s0140-6736(05)63013-9
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发表时间：
2005-05-07
期刊：
影响因子：
168.9
通讯作者：
Wallace, WA
中科院分区：
文献类型：
--
作者：
Grant, AM;Anderson, FH;Wallace, WA
背景 患有骨折的老年人发生骨折的风险很高。通常建议补充维生素 D 和钙来预防骨折。我们的目的是评估维生素 D3 和钙单独或联合使用是否能有效预防继发性骨折。方法 在一项析因设计试验中，5292 名 70 岁或以上的人（其中 4481 名 [85%] 为女性）在发生低创伤性骨折之前可以活动，被随机分配每日 800 IU 口服维生素 D3、1000 毫克钙、口服维生素 D3（每天 800 IU）联合钙（每天 1000 毫克）或安慰剂。对在英国 21 家医院招募的参与者进行了 24 个月至 62 个月的随访。分析采用意向治疗，主要结局是新发低能量骨折。结果显示，5292 名参与者中有 698 名（13%）发生新发低创伤性骨折，其中 183 名（26%）为髋部骨折。分配钙剂的参与者和未分配钙剂的参与者之间，新发低创伤性骨折的发生率没有显着差异（2617 人中的 331 人 [12.6%] vs 2675 人中的 367 人 [13.7%]；风险比 (HR) 0.94 [95% Cl 0.81-1.09]）；分配了维生素 D3 的参与者与未分配维生素 D3 的参与者之间的差异（2649 人中的 353 人 [13.3%] vs 2643 人中的 345 人 [13.1%]；1.02 [0.88-1.19]）；或在分配联合治疗的患者和分配安慰剂的患者之间（1306 人中的 165 人 [12.6%] vs 1332 人中的 179 人 [13.4%]；交互作用项的 HR 为 1.01 [0.75-1.36]）。各组在所有新发骨折、放射线检查证实的骨折、髋部骨折、死亡、跌倒次数或生活质量方面没有差异。到 24 个月时，5292 人中的 2886 人 (54.5%) 仍在服用药片，451 人 (8.5%) 死亡，58 人 (1.1%) 退出，1897 人 (35.8%) 已停止服用药片，但至少仍在提供主要结局的数据。含钙片剂的依从性明显较低（差异：9.4% [95% CI 6.6-12.2]），部分原因是胃肠道症状。然而，潜在的严重不良事件很少见，并且在各组之间没有差异。 解释 研究结果不支持常规口服钙和维生素 D3 单独或组合补充剂来预防以前活动的老年人进一步骨折。
Background Elderly people who have a fracture are at high risk of another. Vitamin D and calcium supplements are often recommended for fracture prevention. We aimed to assess whether vitamin D3 and calcium, either alone or in combination, were effective in prevention of secondary fractures.Methods In a factorial-design trial, 5292 people aged 70 years or older (4481 [85%] of whom were women) who were mobile before developing a low-trauma fracture were randomly assigned 800 IU daily oral vitamin D3, 1000 mg calcium, oral vitamin D3 (800 IU per day) combined with calcium (1000 mg per day), or placebo. Participants who were recruited in 21 UK hospitals were followed up for between 24 months and 62 months. Analysis was by intention-to-treat and the primary outcome was new low-energy fractures.Findings 698 (13%) of 5292 participants had a new low-trauma fracture, 183 (26%) of which were of the hip. The incidence of new, low-trauma fractures did not differ significantly between participants allocated calcium and those who were not (331 [12.6%] of 2617 vs 367 [13.7%] of 2675; hazard ratio (HR) 0.94 [95% Cl 0.81-1.09]); between participants allocated vitamin D3 and those who were not (353 [13.3%] of 2649 vs 345 [13.1%] of 2643; 1.02 [0.88-1.19]); or between those allocated combination treatment and those assigned placebo (165 [12.6%] of 1306 vs 179 [13.4%] of 1332; HR for interaction term 1.01 [0.75-1.36]). The groups did not differ in the incidence of all new fractures, fractures confirmed by radiography, hip fractures, death, number of falls, or quality of life. By 24 months, 2886 (54.5%) of 5292 were still taking tablets, 451 (8.5%) had died, 58 (1.1%) had withdrawn, and 1897 (35.8%) had stopped taking tablets but were still providing data for at least the main outcomes. Compliance with tablets containing calcium was significantly lower (difference: 9.4% [95% CI 6.6-12.2]), partly because of gastrointestinal symptoms. However, potentially serious adverse events were rare and did not differ between groups.Interpretation The findings do not support routine oral supplementation with calcium and vitamin D3, either alone or in combination, for the prevention of further fractures in previously mobile elderly people.