Department of Endocrinology, Columbia University College of Physicians and Surgeons, New York, NY, USA.
Radius Health, Inc., Waltham, MA, USA.
Osteoporos Int. 2018 Feb;29(2):323-328. doi: 10.1007/s00198-017-4304-9. Epub 2017 Nov 22.
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.
评估皮下给予阿巴洛肽（abaloparatide-SC）对绝经后骨质疏松症（PMOP）患者骨骼微结构的影响，该影响通过骨小梁评分（TBS）间接评估。
这是一项 2 期临床试验的事后分析，纳入 222 名 55-85 岁的 PMOP 绝经后妇女，随机接受 abaloparatide-SC（20、40 或 80μg）、皮下特立帕肽（20μg）或安慰剂治疗 24 周。138 名符合腰椎双能 X 线吸收法（DXA）设备 TBS 软件兼容性的患者进行了腰椎 DXA 图像的 TBS 测量。在基线、12 周和 24 周时进行评估。采用广义估计方程，根据相关基线特征进行调整，对组间差异进行评估，并进行了预先设定的最小有意义变化分析。
24 周后，与基线相比，每日接受 20、40 和 80μg abaloparatide-SC 的患者的 TBS 分别显著增加 2.27%、3.14%和 4.21%，每日接受特立帕肽的患者的 TBS 增加 2.21%（p<0.05）。安慰剂组的 TBS 下降 1.08%。调整年龄、BMI 和基线 TBS 后，与安慰剂相比，24 周时各治疗组的 TBS 增加均显著更高（p<0.0001）。在三个 abaloparatide-SC 剂量组和安慰剂组中，在 24 周时观察到剂量反应（p=0.02）。与特立帕肽相比，abaloparatide-SC 80μg 组的 TBS 增加更显著（p<0.03）。
这些结果与 abaloparatide-SC 改善腰椎骨骼微结构的作用一致，通过 TBS 进行评估。
