Patient level pooled analysis of 68 500 patients from seven major vitamin D fracture trials in US and Europe
Patient level pooled analysis of 68 500 patients from seven major vitamin D fracture trials in US and Europe
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DOI：
10.1136/bmj.b5463
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发表时间：
2010-01-12
影响因子：
105.7
通讯作者：
Francis, R. M.
中科院分区：
文献类型：
--
作者：
Abrahamsen, B.;Masud, T.;Francis, R. M.
目的确定影响维生素D或维生素D加钙对任何骨折、髋部骨折和临床脊椎骨折的抗骨折疗效的受试者的特征，并评估给药方案和钙的联合给药的影响。数据来源：7项主要的维生素D单独加钙或维生素D的随机试验，共产生68517名参与者(平均年龄69.9岁，范围47-107岁，14.7%的男性)。研究选择研究包括至少一次干预的随机研究，其中给予维生素D，结果是骨折，数据综合Logistic回归分析确定有意义的交互作用项，然后使用Cox比例风险模型，其中包括年龄、性别、骨折病史、激素治疗和双磷酸盐的使用。结果使用维生素D和钙的试验显示，总体风险降低(风险比0.92，95%可信区间0.86至0.99，P=0.025)和髋部骨折(所有研究：0.84，0.70至1.01，P=0.07；服用维生素D 10 mg加钙：0.74，0.60~0.91，P=0.005)。单独每日剂量为10或20微克的维生素D，未发现明显的影响。骨折病史和治疗反应之间没有交互作用，也没有年龄、性别和激素替代疗法之间的交互作用。结论这一个体患者数据分析表明，单独服用10-20mg维生素D对预防骨折没有效果。相比之下，钙和维生素D一起服用可以减少髋部骨折和完全骨折，甚至可能减少脊椎骨折，而不考虑年龄、性别或既往骨折史。
Objectives To identify participants' characteristics that influence the anti-fracture efficacy of vitamin D or vitamin D plus calcium with respect to any fracture, hip fracture, and clinical vertebral fracture and to assess the influence of dosing regimens and co-administration of calcium.Design Individual patient data analysis using pooled data from randomised trials.Data sources Seven major randomised trials of vitamin D with calcium or vitamin D alone, yielding a total of 68 517 participants (mean age 69.9 years, range 47-107 years, 14.7% men).Study selection Studies included were randomised studies with at least one intervention arm in which vitamin D was given, fracture as an outcome, and at least 1000 participants.Data synthesis Logistic regression analysis was used to identify significant interaction terms, followed by Cox's proportional hazards models incorporating age, sex, fracture history, and hormone therapy and bisphosphonate use.Results Trials using vitamin D with calcium showed a reduced overall risk of fracture (hazard ratio 0.92, 95% confidence interval 0.86 to 0.99, P=0.025) and hip fracture (all studies: 0.84, 0.70 to 1.01, P=0.07; studies using 10 mu g of vitamin D given with calcium: 0.74, 0.60 to 0.91, P=0.005). For vitamin D alone in daily doses of 10 mu g or 20 mu g, no significant effects were found. No interaction was found between fracture history and treatment response, nor any interaction with age, sex, or hormone replacement therapy.Conclusion This individual patient data analysis indicates that vitamin D given alone in doses of 10-20 mu g is not effective in preventing fractures. By contrast, calcium and vitamin D given together reduce hip fractures and total fractures, and probably vertebral fractures, irrespective of age, sex, or previous fractures.