Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.
New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, USA.
J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.
In the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) clinical trial (NCT01631214), 1 year of romosozumab followed by alendronate reduced the risk of vertebral and nonvertebral fractures compared to alendronate alone in women with prevalent fracture. We performed post hoc analyses of data from patients in ARCH (romosozumab, n = 1739; alendronate, n = 1726) who had a baseline BMD measurement and received at least one open-label alendronate dose. We evaluated 1-year mean BMD and corresponding T-score changes; proportions of patients achieving T-scores > -2.5 at the total hip (TH), femoral neck (FN), and lumbar spine (LS); and group differences in fracture rates after 12 months, while all participants were on alendronate. Subsequently, we investigated the relationship between T-scores achieved at the TH, FN, and LS at 12 months and subsequent fracture incidence. At 1 year, mean change from baseline in TH BMD was 6.3% (T-score change 0.31) with romosozumab versus 2.9% (T-score change 0.15) with alendronate (p < .001). The proportion of patients with TH T-score > -2.5 increased from 34% at baseline to 55% after 1 year of romosozumab and from 32% at baseline to 44% after 1 year of alendronate. Compared with patients receiving alendronate in year 1, those receiving romosozumab had a 75% reduction in new or worsening vertebral fracture (p < .001) in year 2, and a 19% reduction in nonvertebral fracture (p = .120) and 40% reduction in hip fracture (p = .041) during the open-label period. TH and FN T-scores achieved at month 12 were associated with subsequent nonvertebral and vertebral fracture rates and the relationships were independent of treatment received. LS T-score at 12 months was associated with vertebral but not nonvertebral fracture risk. We conclude that 1 year of romosozumab leads to larger BMD gains versus alendronate, and that the T-score achieved with either therapy is related to subsequent fracture risk. These data support the use of T-score as a therapeutic target for patients with osteoporosis. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.
在绝经后骨质疏松症高危女性的活性对照骨折研究（ARCH）临床试验（NCT01631214）中，与单独使用阿伦膦酸盐相比，罗莫佐单抗治疗 1 年可降低已发生骨折的女性椎体和非椎体骨折的风险。我们对 ARCH 中的患者数据进行了事后分析（罗莫佐单抗组 n=1739；阿仑膦酸钠组 n=1726），这些患者基线时有骨密度测量值，并且至少接受了一次开放标签的阿仑膦酸钠治疗。我们评估了 1 年的平均骨密度和相应的 T 评分变化；全髋关节（TH）、股骨颈（FN）和腰椎（LS）T 评分>-2.5 的患者比例；以及在所有患者均接受阿仑膦酸钠治疗的情况下，12 个月后的骨折发生率组间差异。随后，我们研究了 12 个月时 TH、FN 和 LS 的 T 评分与随后骨折发生率之间的关系。在 1 年时，与阿仑膦酸钠相比，罗莫佐单抗治疗后 TH 骨密度的平均基线变化为 6.3%（T 评分变化 0.31），而阿仑膦酸钠为 2.9%（T 评分变化 0.15）（p<0.001）。TH T 评分>-2.5 的患者比例从基线时的 34%增加到罗莫佐单抗治疗 1 年后的 55%，从基线时的 32%增加到阿仑膦酸钠治疗 1 年后的 44%。与第 1 年接受阿仑膦酸钠治疗的患者相比，第 2 年接受罗莫佐单抗治疗的患者新发生或加重的椎体骨折发生率降低了 75%（p<0.001），非椎体骨折发生率降低了 19%（p=0.120），髋部骨折发生率降低了 40%（p=0.041）在开放标签期间。第 12 个月时 TH 和 FN 的 T 评分与随后的非椎体和椎体骨折发生率相关，并且这些关系独立于所接受的治疗。第 12 个月时 LS 的 T 评分与椎体骨折相关，但与非椎体骨折无关。我们得出结论，1 年的罗莫佐单抗治疗比阿仑膦酸钠治疗骨密度增加更大，且两种治疗方法的 T 评分与随后的骨折风险相关。这些数据支持将 T 评分作为骨质疏松症患者的治疗目标。 © 2020 美国骨矿研究学会。
