背景:骨质疏松性椎体压缩性骨折(OVCFs)是常见的脆性骨折。接受初始OVCF手术治疗的患者需要特别注意,因为随后的椎骨骨折和其他类型的脆性骨折的风险增加。然而,对该特定患者组的最佳骨质疏松症治疗研究较少。
目的:本研究比较了使用地诺塞马和双膦酸盐治疗的患者随后发生骨质疏松性骨折的风险和死亡率,并确定了坚持治疗的效果。
方法:回顾性全国队列研究患者样本:共有2,858例经手术治疗的骨质疏松性椎体压缩骨折患者。
方法:骨质疏松性骨折的风险,椎骨骨折,非椎骨骨折和死亡。
方法:这是一项使用国家健康保险研究数据库的全国性回顾性队列研究。包括年龄≥50岁的患者,他们在2012年至2016年期间接受OVCF手术干预,随后接受denosumab或双膦酸盐治疗一年。根据患者的抗骨质疏松药物和治疗依从性进行分层。多变量,时变Cox比例风险模型用于确定骨质疏松性骨折的风险,椎骨骨折,非椎骨骨折和死亡。
结果:本研究共纳入2,858例患者:denosumab组1,123例患者,双膦酸盐组1,735例患者。与持久的denosumab用户相比,非持久性denosumab用户,持续性双膦酸盐使用者和非持续性双膦酸盐使用者患骨质疏松性骨折的风险更大,各自的风险比为1.64(95%置信区间[CI],1.16-2.32),1.74(95%CI,1.25-2.42)和1.53(95%CI,1.14-2.06)。如果将骨质疏松性骨折分为非椎体骨折和椎体骨折,与持续使用denosumab的患者相比,没有一组患者的椎骨骨折风险增加,非持久性denosumab用户的HR为1.00(95%CI:0.54-1.88),持续性双膦酸盐使用者为1.64(95%CI:0.96-2.81),非持续性双膦酸盐使用者为1.52(95%CI:0.95-2.43)。然而,非椎骨骨折的风险明显更大,各自的风险比为2.04(95%CI,1.33-3.11),非持久性denosumab用户的1.80(95%CI,1.18-2.76)和1.56(95%CI,1.06-2.27),持久性双膦酸盐使用者和非持久性使用者。值得注意的是,非持续性denosumab使用者比持续性denosumab使用者表现出更大的死亡风险,风险比为3.12(95%CI,2.22-4.38)。
结论:对于需要住院治疗和手术干预的OVCF患者,与接受双膦酸盐或非持续性地诺塞马治疗的患者相比,接受持续地诺塞马治疗的患者随后发生骨质疏松性骨折的风险较低.然而,停用denosumab与后续骨折和死亡率的风险显著增加相关.因此,坚持治疗对于使用denosumab的患者至关重要。
BACKGROUND: Osteoporotic vertebral compression fractures (OVCFs) are common fragility fractures. Patients who undergo surgical treatment for their initial OVCFs warrant particular attention because there is an elevated risk of subsequent vertebral fractures and other types of fragility fractures. However, the optimal osteoporosis treatment for this specific patient group is less investigated.
OBJECTIVE: This
study compares the risk of subsequent osteoporotic fractures and mortality rate for patients who are initiated with denosumab and bisphosphonates and determines the effect of adherence to treatment.
METHODS: Retrospective nationwide cohort
study PATIENT SAMPLE: A total of 2,858 patients who had surgically-managed osteoporotic vertebral compression fractures.
METHODS: The risk of osteoporotic fractures, vertebral fractures, non-vertebral fractures and death.
METHODS: This is a retrospective nationwide cohort
study that uses the National Health Insurance Research Database. Patients aged ≥50 years who were admitted for surgical interventions for OVCF between 2012 and 2016 and subsequently received denosumab or bisphosphonates for one year were included. Patients were stratified according to their anti-osteoporosis medications and adherence to treatment. A multivariable, time-varying Cox proportional hazards model was used to determine the risk of osteoporotic fractures, vertebral fractures, non-vertebral fractures and death.
RESULTS: A total of 2,858 patients were included in this
study: 1,123 patients in the denosumab group and 1,735 patients in the bisphosphonates group. Compared to persistent denosumab users, the non-persistent denosumab users, persistent bisphosphonate users and non-persistent bisphosphonate users had a greater risk of osteoporotic fractures, with respective hazard ratios of 1.64 (95% confidence interval [CI], 1.16-2.32), 1.74 (95% CI, 1.25-2.42) and 1.53 (95% CI, 1.14-2.06). If osteoporotic fractures were divided into non-vertebral and vertebral fractures, none of the groups exhibited an increased risk of vertebral fractures compared to persistent denosumab users, with an HR of 1.00 (95% CI: 0.54-1.88) for non-persistent denosumab users, 1.64 (95% CI: 0.96-2.81) for persistent bisphosphonate users and 1.52 (95% CI: 0.95-2.43) for non-persistent bisphosphonate users. However, there was a significantly greater risk of non-vertebral fracture, with respective hazard ratios of 2.04 (95% CI, 1.33-3.11), 1.80 (95% CI, 1.18-2.76) and 1.56 (95% CI, 1.06-2.27) for non-persistent denosumab users, persistent bisphosphonate users and non-persistent users. Noteworthy, non-persistent denosumab users exhibited a significantly greater risk of mortality than persistent denosumab users, with a hazard ratio of 3.12 (95% CI, 2.22-4.38).
CONCLUSIONS: In terms of patients with OVCFs who require hospitalization and surgical intervention, those who receive ongoing denosumab treatment exhibit less risk of developing subsequent osteoporotic fractures than those who receive bisphosphonates or non-persistent denosumab treatment. However, discontinuation of denosumab is associated with a significantly increased risk of subsequent fractures and mortality. Therefore, adherence to the treatment is crucial for patients who are initiated with denosumab.