Department of Orthopedic Surgery, Seoul National University Bundang Hospital, Seongnam, Korea.
Division of Statistics, Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Korea.
J Korean Med Sci. 2020 Jun 29;35(25):e193. doi: 10.3346/jkms.2020.35.e193.
Concern about bisphosphonate-associated subtrochanteric and femoral shaft (ST/FS) fractures has been raised. However, its real risk is still debatable, because there is no study to estimate risk and benefit of bisphosphonate. The objective of this study was to evaluate the risk of typical hip fractures and ST/FS fractures among bisphosphonate users using nationwide database.
We performed a retrospective cohort study using National Health Insurance Service-National Sample Cohort. We evaluated occurrence of the ST/FS and femoral neck and intertrochanteric (FN/IT) fractures among female bisphosphonate new users. Incidence rate of ST/FS and FN/IT fractures were compared between long-term users (≥ 1 year) and short-term users (< 1 year). Number needed to harm (NNH) for ST/FS and number needed to treat (NNT) for typical hip fracture were analyzed.
Among 46,420 bisphosphonate users, we identified 14,689 long-term users and 21,840 short-term users. During the study period, 61 long-term users and 36 short-term users had ST/FS fractures, while 204 long-term users and 511 short-term users had FN/IT fractures. The long-term user showed higher incidence rate of ST/FS fractures (67.1/100,000 person-years; 95% confidence interval [CI], 50.3-83.9) comparing with 31.2/100,000 person-years (95% CI, 21.0-41.4) in the short-term users. The incidence rate of FN/IT fractures was 225.5/100,000 person-years (95% CI, 194.6-256.5) in the long-term users and 448.6/100,000 person-years (95% CI, 409.7-487.5) in the short-term users. The NNH for ST/FS was 400, while the NNT for typical hip fracture was 105.
Our study suggested that physicians keep the significant benefit of bisphosphonate to prevent typical hip fracture in mind, even the concerns about bisphosphonate-associated ST/FS fractures.
人们对双膦酸盐相关的转子下和股骨干(ST/FS)骨折的担忧已经提出。然而,其真正的风险仍存在争议,因为目前尚无研究来评估双膦酸盐的风险和获益。本研究旨在使用全国性数据库评估双膦酸盐使用者发生典型髋部骨折和 ST/FS 骨折的风险。
我们使用国民健康保险服务-全国抽样队列进行了回顾性队列研究。我们评估了女性双膦酸盐新使用者中 ST/FS 和股骨颈及转子间(FN/IT)骨折的发生情况。比较了长期使用者(≥1 年)和短期使用者(<1 年)的 ST/FS 和 FN/IT 骨折发生率。分析了 ST/FS 和典型髋部骨折的需要治疗人数(NNT)。
在 46420 名双膦酸盐使用者中,我们确定了 14689 名长期使用者和 21840 名短期使用者。在研究期间,61 名长期使用者和 36 名短期使用者发生了 ST/FS 骨折,而 204 名长期使用者和 511 名短期使用者发生了 FN/IT 骨折。与短期使用者(95%置信区间[CI],21.0-41.4)相比,长期使用者发生 ST/FS 骨折的发生率更高(67.1/100000 人年;95%CI,50.3-83.9)。长期使用者 FN/IT 骨折的发生率为 225.5/100000 人年(95%CI,194.6-256.5),短期使用者为 448.6/100000 人年(95%CI,409.7-487.5)。ST/FS 的 NNH 为 400,而典型髋部骨折的 NNT 为 105。
本研究提示医生在考虑双膦酸盐相关 ST/FS 骨折的同时,牢记双膦酸盐预防典型髋部骨折的显著获益。