唑来膦酸与阿仑膦酸钠治疗下首次髋部骨折的风险：一项对挪威 88000 名门诊治疗男女患者的 NOREPOS 队列研究。

Risk of first hip fracture under treatment with zoledronic acid versus alendronate: a NOREPOS cohort study of 88,000 Norwegian men and women in outpatient care.

机构信息

Norwegian Research Centre for Women's Health, Oslo University Hospital, Oslo, Norway.

Department of Physical Health and Ageing, Norwegian Institute of Public Health, Oslo, Norway.

出版信息

Arch Osteoporos. 2024 Oct 23;19(1):102. doi: 10.1007/s11657-024-01458-4.

DOI:10.1007/s11657-024-01458-4

PMID:39443347

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11499353/

Abstract

UNLABELLED

We aimed to investigate the risk of hip fracture associated with zoledronic acid treatment compared to alendronate on a population level. The risk of hip fracture was lower in women using zoledronic acid and higher in women who had discontinued treatment. The findings support the effectiveness of intravenous bisphosphonate.

PURPOSE

To investigate whether zoledronic acid (ZOL) was associated with a lower risk of the first hip fracture than alendronate (ALN) in Norway using real-world data.

METHODS

Nationwide data on drugs dispensed in outpatient pharmacies were individually linked with all hospital-treated hip fractures. Individuals aged 50-89 years without previous hip fracture were included at their first filling of a prescription for ALN or ZOL during 2005-2016. Hazard ratios (HRs) with 95% confidence intervals (95% CIs) for first hip fracture by time-varying exposure to ZOL versus ALN were estimated in sex-stratified flexible parametric survival analyses. Covariates included time-varying accumulated ALN exposure and comorbidity level expressed by the prescription-based Rx-Risk Comorbidity Index, marital status, education, and residential urbanity.

RESULTS

Of 75,250 women who initiated treatment, 72,614 (96.5%) were exposed to ALN and 6366 (8.5%) to ZOL. Of 12,739 men who initiated treatment, 12,311 (96.6%) were exposed to ALN and 784 (6.2%) to ZOL. In women, the HR for first hip fracture was 0.75 (95% CI: 0.61-0.91) for ZOL versus ALN. In men, the corresponding HR was 0.59 (95% CI: 0.32-1.07). Discontinued treatment was associated with increased risk compared with current ALN treatment in women (HR: 1.33; 95% CI: 1.24-1.42, men: HR 1.13 (95% CI: 0.95-1.35)).

CONCLUSIONS

In women, the risk of first hip fracture when treated with ZOL was 25% lower than when treated with ALN. Discontinued treatment was associated with a 33% increase in hip fracture risk. Similar, albeit statistically non-significant, results were observed in men.

摘要

目的

利用挪威的真实世界数据，调查唑来膦酸（zoledronic acid，ZOL）与阿仑膦酸钠（alendronate，ALN）相比，是否能降低髋部骨折风险。

方法

对 2005 年至 2016 年期间在门诊药房配药的个人进行全国性数据与所有经医院治疗的髋部骨折的个体链接。将年龄 50-89 岁、无既往髋部骨折的个体纳入研究，他们在首次处方 ALN 或 ZOL 时被纳入研究。通过时间依赖性暴露于 ZOL 与 ALN 的分层灵活参数生存分析，估计首次髋部骨折的风险比（hazard ratio，HR）及其 95%置信区间（95% confidence interval，95%CI）。协变量包括时间依赖性累积 ALN 暴露和以 Rx-Risk 共病指数（prescription-based Rx-Risk Comorbidity Index）表示的共病水平、婚姻状况、教育程度和居住城市化程度。

结果

在 75250 名开始治疗的女性中，72614 名（96.5%）暴露于 ALN，6366 名（8.5%）暴露于 ZOL。在 12739 名开始治疗的男性中，12311 名（96.6%）暴露于 ALN，784 名（6.2%）暴露于 ZOL。在女性中，ZOL 与 ALN 相比，首次髋部骨折的 HR 为 0.75（95%CI：0.61-0.91）。在男性中，相应的 HR 为 0.59（95%CI：0.32-1.07）。与当前的 ALN 治疗相比，停药与女性髋部骨折风险增加相关（HR：1.33；95%CI：1.24-1.42，男性：HR 1.13（95%CI：0.95-1.35））。