Summary

TBS algorithm has been updated to account for regional soft tissue noise. In postmenopausal women with osteoporosis, denosumab improved tissue thickness–adjusted TBS vs placebo independently of bone mineral density over 3 years, with the magnitude of changes from baseline or placebo numerically greater than body mass index–adjusted TBS.

Introduction

To evaluate the effect of denosumab on bone microarchitecture assessed by trabecular bone score (TBS) in the FREEDOM study using the updated algorithm that accounts for regional soft tissue thickness (TBS_TT) in dual-energy X-ray absorptiometry (DXA) images and to compare percent changes from baseline and placebo with classical body mass index (BMI)–adjusted TBS (TBS_BMI).

Methods

Postmenopausal women with lumbar spine or total hip bone mineral density (BMD) T score < − 2.5 and ≥ − 4.0 received placebo or denosumab 60 mg subcutaneously every 6 months. TBS_BMI and TBS_TT were assessed on lumbar spine DXA scans at baseline and months 1, 12, 24, and 36 in a subset of 279 women (129 placebo, 150 denosumab) who completed the 3-year FREEDOM DXA substudy and rolled over to open-label extension study.

Results

Baseline characteristics were similar between groups. TBS_TT in the denosumab group showed numerically greater changes from both baseline and placebo than TBS_BMI at months 12, 24, and 36. Denosumab led to progressive increases in BMD (1.2, 5.6, 8.1, and 10.5%) and TBS_TT (0.4, 2.3, 2.6, and 3.3%) from baseline to months 1, 12, 24, and 36, respectively. Both TBS changes were significant vs baseline and placebo from months 12 to 36 (p < 0.0001). As expected, BMD and TBS_TT were poorly correlated both at baseline and for changes during treatment.

Conclusion

In postmenopausal women with osteoporosis, denosumab significantly improved bone microstructure assessed by TBS_TT over 3 years. TBS_TT seemed more responsive to denosumab treatment than TBS_BMI and was independent of BMD.

中文翻译：

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在 FREEDOM TBS 事后分析中，考虑到软组织厚度 (TBSTT) 的更新的骨小梁评分显示使用地诺单抗显着改善了骨微观结构

概括

TBS 算法已更新以考虑区域软组织噪声。在患有骨质疏松症的绝经后女性中，与安慰剂相比，狄诺塞麦在 3 年内独立于骨矿物质密度改善了组织厚度调整的 TBS，与基线或安慰剂相比的变化幅度在数值上大于体重指数调整的 TBS。

介绍

在 FREEDOM 研究中使用更新的算法评估狄诺塞麦对通过骨小梁评分 (TBS) 评估的骨微结构的影响，该算法考虑了双能 X 射线吸收测定 (DXA) 图像中的区域软组织厚度 (TBS _TT )，并比较基线和安慰剂与经典体重指数 (BMI) 调整的 TBS (TBS _BMI ) 的百分比变化。

方法

腰椎或总髋骨矿物质密度 (BMD) T 评分 < - 2.5 和 ≥ - 4.0 的绝经后妇女每 6 个月接受安慰剂或地诺单抗 60 mg 皮下注射。TBS _BMI和 TBS _TT在完成 3 年 FREEDOM DXA 子研究并转入至开放标签扩展研究。

结果

各组之间的基线特征相似。在第 12、24 和 36 个月时，狄诺塞麦组的TBS _TT与基线和安慰剂相比在数值上的变化大于 TBS _BMI。狄诺塞麦导致 BMD（1.2、5.6、8.1 和 10.5%）和 TBS _TT（0.4 、2.3、2.6 和 3.3%）分别从基线到第 1、12、24 和 36 个月。从第 12 个月到第 36 个月，与基线和安慰剂相比，TBS 的变化均显着（p  < 0.0001）。正如预期的那样，BMD 和 TBS _TT在基线和治疗期间的变化方面的相关性都很差。

结论

在患有骨质疏松症的绝经后妇女中，狄诺塞麦在 3 年内显着改善了通过 TBS _{TT评估的骨微观结构。}TBS _TT似乎比 TBS _BMI对地诺单抗治疗更敏感，并且与 BMD 无关。