Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial.
Abaloparatide-SC improves trabecular microarchitecture as assessed by trabecular bone score (TBS): a 24-week randomized clinical trial.
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DOI：
10.1007/s00198-017-4304-9
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发表时间：
2018-03
期刊：
影响因子：
--
通讯作者：
Hans D
中科院分区：
文献类型：
--
作者：
Bilezikian JP;Hattersley G;Fitzpatrick LA;Harris AG;Shevroja E;Banks K;Leder BZ;Zanchetta JR;Hans D
在一项2期试验中，222名年龄在55至85岁的绝经后骨质疏松症女性随机接受三种不同剂量的阿巴帕肽-SC、皮下特立帕利肽或安慰剂治疗24周，阿巴帕肽-SC导致骨小梁评分测量的骨骼微结构改善。皮下注射阿巴帕肽（阿巴帕肽-SC）可增加总髋关节和腰椎骨密度，减少椎体和非椎体骨折。在这项研究中，我们分析了阿巴帕肽SC改善骨骼微结构的程度，通过骨小梁评分（TBS）间接评估。这是一项II期试验的事后分析，纳入222名年龄在55至85岁之间的绝经后骨质疏松症女性，随机接受阿巴帕肽-SC（20、40或80 μ g）、皮下特立帕肽（20 μ g）或安慰剂治疗24周。TBS是从腰椎双X线吸收测定法（DXA）的138名妇女的DXA设备是TBS软件兼容的图像测量。在基线、12周和24周进行评估。通过校正相关基线特征的广义估计方程评估组间差异，并进行预先确定的最小显著变化分析。24周后，每日皮下注射20、40和80 μ g阿巴帕肽的受试者的TBS分别较基线显著增加2.27、3.14和4.21%，特立帕肽组的TBS较基线显著增加2.21%（各p <0.05）。安慰剂组的TBS下降了1.08%。校正年龄、BMI和基线TBS后，24周时每个治疗组的TBS增加均显著高于安慰剂组（每个组p <0.0001）。在24周时，在三种剂量的阿巴帕肽-SC和安慰剂中观察到剂量反应（p = 0.02）。阿巴帕肽-SC 80 μ g组中TBS的增加显著大于TPTD（p <0.03）。根据TBS评估，这些结果与阿巴帕肽-SC改善腰椎骨骼微结构的作用一致。
In a phase 2 trial of 222 postmenopausal women with osteoporosis aged 55 to 85 years randomized to one of three different doses of abaloparatide-SC, subcutaneous teriparatide, or placebo for 24 weeks, abaloparatide-SC resulted in improvements in skeletal microarchitecture as measured by the trabecular bone score. Subcutaneous abaloparatide (abaloparatide-SC) increases total hip and lumbar spine bone mineral density and reduces vertebral and non-vertebral fractures. In this study, we analyzed the extent to which abaloparatide-SC improves skeletal microarchitecture, assessed indirectly by trabecular bone score (TBS). This is a post hoc analysis of a phase 2 trial of 222 postmenopausal women with osteoporosis aged 55 to 85 years randomized to abaloparatide-SC (20, 40, or 80 μg), subcutaneous teriparatide (20 μg), or placebo for 24 weeks. TBS was measured from lumbar spine dual X-ray absorptiometry (DXA) images in 138 women for whom the DXA device was TBS software compatible. Assessments were made at baseline, 12 and 24 weeks. Between-group differences were assessed by generalized estimating equations adjusted for relevant baseline characteristics, and a pre-determined least significant change analysis was performed. After 24 weeks, TBS increased significantly by 2.27, 3.14, and 4.21% versus baseline in participants on 20, 40, and 80 μg abaloparatide-SC daily, respectively, and by 2.21% in those on teriparatide (p < 0.05 for each). The TBS in the placebo group declined by 1.08%. The TBS increase in each treatment group was significantly higher than placebo at 24 weeks (p < 0.0001 for each) after adjustment for age, BMI, and baseline TBS. A dose-response was observed at 24 weeks across the three doses of abaloparatide-SC and placebo (p = 0.02). The increase in TBS in the abaloparatide-SC 80 μg group was significantly greater than TPTD (p < 0.03). These results are consistent with an effect of abaloparatide-SC to improve lumbar spine skeletal microarchitecture, as assessed by TBS.
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影响因子：
2.5
作者：
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