WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.
Osteoporos Int. 2014 Jan;25(1):235-41. doi: 10.1007/s00198-013-2460-0. Epub 2013 Aug 22.
In this meta-analysis of the control arms of four phase 3 trials, mild vertebral fractures were a significant risk factor for future vertebral fractures but not for non-vertebral fracture.
A prior vertebral fracture is a risk factor for future fracture that is commonly used as an eligibility criterion for treatment and in the assessment of fracture probability. The aim of this study was to determine the prognostic significance of a morphometric fracture according to the severity of fracture.
We examined the control (placebo) treated arms of four phase 3 trials. Vertebral fracture status was graded at baseline in 7,623 women, and fracture outcomes were documented over the subsequent 20,000 patient-years. Fracture outcomes were characterised as a further vertebral fracture, a non-vertebral fracture or a clinical fracture (non-vertebral plus clinical vertebral fracture). The relative risk of fracture was computed from the merged β coefficients of each trial weighted according to the variance.
Mild vertebral fractures were a significant risk factor for vertebral fractures [risk ratio (RR) = 2.17; 95% CI = 1.70-2.76] but were not associated with an increased risk of non-vertebral fractures (RR = 1.08; 95% CI = 0.86-1.36). Moderate/severe vertebral fractures were associated with a high risk of vertebral fractures (RR = 4.23; 95% CI = 3.58-5.00) and a moderate though significant increase in non-vertebral fracture risk (RR = 1.64; 95% CI = 1.38-1.94).
Prior moderate/severe morphometric vertebral fractures are a strong and significant risk factor for future fracture. The presence of a mild vertebral fracture is of no significant prognostic value for non-vertebral fractures. These findings should temper the use of morphometric fractures in the assessment of risk and the design of phase 3 studies.
本研究对四项 III 期临床试验的对照组进行了荟萃分析，结果显示轻度椎体骨折是未来椎体骨折的显著危险因素，但不是非椎体骨折的危险因素。
既往椎体骨折是发生骨折的危险因素，常用于治疗的入选标准以及骨折风险评估。本研究的目的是根据骨折严重程度确定形态计量学骨折的预后意义。
我们研究了四项 III 期临床试验的对照组（安慰剂治疗组）。7623 名女性在基线时对椎体骨折情况进行分级，并在随后的 20000 患者-年中记录骨折结局。骨折结局定义为再次发生椎体骨折、非椎体骨折或临床骨折（非椎体骨折加临床椎体骨折）。每个试验的合并β系数根据方差进行加权，并计算每个试验的相对风险。
轻度椎体骨折是椎体骨折的显著危险因素（RR=2.17；95%CI=1.70-2.76），但与非椎体骨折风险增加无关（RR=1.08；95%CI=0.86-1.36）。中度/重度椎体骨折与椎体骨折风险高（RR=4.23；95%CI=3.58-5.00）以及非椎体骨折风险中度但显著增加（RR=1.64；95%CI=1.38-1.94）相关。
既往中度/重度形态计量学椎体骨折是未来骨折的强烈且显著的危险因素。轻度椎体骨折对非椎体骨折无明显预后意义。这些发现应该缓和形态计量学骨折在风险评估和 III 期研究设计中的应用。
