Human Performance Laboratory, Faculty of Kinesiology, University of Calgary, Calgary, Canada.
McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.
J Bone Miner Res. 2018 Oct;33(10):1729-1740. doi: 10.1002/jbmr.3525. Epub 2018 Jun 28.
Spinal cord injury (SCI) is associated with marked bone loss and an increased risk of fracture. We randomized 61 individuals with chronic SCI and low bone mass to receive either teriparatide 20 μg/d plus sham vibration 10 min/d (n = 20), placebo plus vibration 10 min/d (n = 20), or teriparatide 20 μg/d plus vibration 10 min/d (n = 21). Patients were evaluated for 12 months; those who completed were given the opportunity to participate in an open-label extension where all participants (n = 25) received teriparatide 20 μg/d for an additional 12 months and had the optional use of vibration (10 min/d). At the end of the initial 12 months, both groups treated with teriparatide demonstrated a significant increase in areal bone mineral density (aBMD) at the spine (4.8% to 5.5%). The increase in spine aBMD was consistent with a marked response in serum markers of bone metabolism (ie, CTX, P1NP, BSAP), but no treatment effect was observed at the hip. A small but significant increase (2.2% to 4.2%) in computed tomography measurements of cortical bone at the knee was observed in all groups after 12 months; however, the magnitude of response was not different amongst treatment groups and improvements to finite element-predicted bone strength were not observed. Teriparatide treatment after the 12-month extension resulted in further increases to spine aBMD (total increase from baseline 7.1% to 14.4%), which was greater in patients initially randomized to teriparatide. Those initially randomized to teriparatide also demonstrated 4.4% to 6.7% improvements in hip aBMD after the 12-month extension, while all groups displayed increases in cortical bone measurements at the knee. To summarize, teriparatide exhibited skeletal activity in individuals with chronic SCI that was not augmented by vibration stimulation. Without additional confirmatory data, the location-specific responses to teriparatide would not be expected to provide clinical benefit in this population. © 2018 American Society for Bone and Mineral Research.
脊髓损伤（SCI）与明显的骨丢失和骨折风险增加有关。我们将 61 名患有慢性 SCI 和低骨量的个体随机分为三组：分别接受特立帕肽 20μg/d 加假振动 10 分钟/d（n=20）、安慰剂加振动 10 分钟/d（n=20）或特立帕肽 20μg/d 加振动 10 分钟/d（n=21）。患者接受了 12 个月的评估；完成评估的患者有机会参加开放标签扩展研究，所有参与者（n=25）接受特立帕肽 20μg/d 治疗 12 个月，并可选择使用振动（10 分钟/d）。在最初的 12 个月结束时，两组特立帕肽治疗组的脊柱骨矿物质密度（aBMD）均显著增加（4.8%至 5.5%）。脊柱 aBMD 的增加与骨代谢血清标志物（即 CTX、P1NP、BSAP）的明显反应一致，但髋部没有观察到治疗效果。所有组在 12 个月后膝关节皮质骨的计算机断层扫描（CT）测量均观察到较小但有统计学意义的增加（2.2%至 4.2%）；然而，治疗组之间的反应幅度没有差异，也没有观察到有限元预测骨强度的改善。12 个月扩展研究后，特立帕肽治疗导致脊柱 aBMD 进一步增加（从基线总增加 7.1%至 14.4%），最初随机接受特立帕肽治疗的患者增加幅度更大。12 个月扩展研究后，最初随机接受特立帕肽治疗的患者髋部 aBMD 也有 4.4%至 6.7%的改善，所有组的膝关节皮质骨测量值均增加。总之，特立帕肽在慢性 SCI 患者中表现出骨骼活性，而振动刺激并未增强这种活性。在没有额外的确认性数据的情况下，预计这种人群中特立帕肽的特定部位反应不会带来临床获益。© 2018 美国骨矿研究学会。
