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Distribution of Prevalent and Incident Vertebral Fractures and Their Association with Bone Mineral Density in Postmenopausal Women in the Teriparatide Versus Risedronate VERO Clinical Trial.
Calcified Tissue International ( IF 4.2 ) Pub Date : 2020-03-10 , DOI: 10.1007/s00223-020-00683-6
Piet Geusens 1 , David L Kendler 2 , Astrid Fahrleitner-Pammer 3 , Pedro López-Romero 4 , Fernando Marin 4
Affiliation  

Vertebral fractures (VFx) occur most frequently in the mid-thoracic and thoraco-lumbar regions, which experience the highest mechanical loading along the spine. The prevalence and incidence of VFx by their location and severity, and their relationship with bone mineral density (BMD), are seldom reported in randomized clinical trial cohorts. The VERO trial randomized 1360 postmenopausal women with at least two moderate or one severe VFx to receive either teriparatide or risedronate for up to 24 months. In this post hoc analysis, we describe the centrally read distribution and severity of prevalent and incident VFx, and the association of their location with the baseline BMD. At baseline, 21.4% of all evaluable vertebral bodies had a prevalent VFx; most commonly at L1, T12, L2 and T11 (38.5%, 37.4%, 25.3% and 23.5% of patients, respectively). Patients with prevalent VFx only at T12/L1 showed a higher baseline BMD compared to patients with VFx at other levels. At month 24, 100 patients had 126 incident VFx (teriparatide: 35; risedronate: 91). The most frequent incident VFx occurred at T12 (n = 17, 1.6% of patients), followed by L1 and T11 (n = 14, 1.3% both). The frequency of incident VFx was lower at all vertebral levels in patients given teriparatide. These results confirm prior reports that VFx occurs more frequently at mid-thoracic and thoraco-lumbar regions of the spine. Patients with these VFx locations have higher BMD than those who fracture at other sites, suggesting a role for mechanical stress in the etiology of VFx. Teriparatide is superior to risedronate in the prevention of VFx at these common fracture locations.Trial registration ClinicalTrials.gov Identifier: NCT01709110.

中文翻译:

特立帕肽与利塞膦酸钠VERO临床试验中,绝经后妇女中普遍发生的椎骨骨折的分布及其与骨矿物质密度的关系。

椎骨骨折(VFx)最常发生在胸中部和胸腰段,沿脊柱承受最高的机械负荷。VFx的位置和严重程度及其与骨矿物质密度(BMD)的关系的发生率和发生率在随机临床试验队列中很少报道。VERO试验将1360名至少有2名中度或1名严重VFx的绝经后妇女随机分配为接受特立帕肽或利塞膦酸盐治疗长达24个月。在此事后分析中,我们描述了流行性和突发性VFx的集中读取分布和严重性,以及它们的位置与基线BMD的关联。在基线时,所有可评估椎体中21.4%的患者具有普遍的VFx。最常见于L1,T12,L2和T11(分别为38.5%,37.4%,25.3%和23.5%的患者)。与其他水平的VFx患者相比,仅在T12 / L1流行VFx的患者显示出更高的基线BMD。在第24个月,有100名患者发生了126例VFx(特立帕肽:35;利塞膦酸盐:91)。VFx发生最频繁的事件发生在T12(n = 17,占患者的1.6%),其次是L1和T11(n = 14,均为1.3%)。接受特立帕肽治疗的患者在所有椎骨水平上,VFx的发生频率均较低。这些结果证实了先前的报道,即VFx在脊柱的胸中部和胸腰部区域更频繁地发生。具有这些VFx位置的患者的BMD比那些在其他部位骨折的患者更高,这表明机械应力在VFx的病因中起作用。在这些常见的骨折部位,特立帕肽在预防VFx方面优于利塞膦酸盐。临床注册临床试验.gov标识符:NCT01709110。
更新日期:2020-03-10
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