Department of Orthopaedic Surgery, CHA Bundang Medical Center, CHA University, Seongnam-si, Republic of Korea.
Data Science Team, Hanmi Pharm. Co., Ltd, Seoul, Republic of Korea.
Osteoporos Int. 2024 May;35(5):775-783. doi: 10.1007/s00198-024-07022-7. Epub 2024 Jan 19.
With the analysis of nationwide health claim data, treatment with the composite agent of SERMs and vitamin D reduces the risk of osteoporotic fracture and hip fracture better compared to SERMs treatment in women with osteoporosis aged ≥ 50 years.
This study compared the potential of the composite agent of selective estrogen receptor modulators (SERMs) and vitamin D (SERM + VitD) with that of SERMs-only for fracture prevention and mortality reduction in women aged ≥ 50 years.
The incidence of osteoporotic fracture (fractures of the vertebrae, hip, wrist, or humerus) and all-cause death after treatment with SERM + VitD and SERMs were characterized using the Korean National Health Insurance Service database 2017-2019. The participants were divided into two groups (SERM + VitD vs SERMs). After exclusion and propensity score matching, 2,885 patients from each group were included in the analysis. Fracture incidence was compared between groups. Kaplan-Meier curves were used to compare mortality. Cox proportional hazards regression analysis was used to compare the risks of fracture occurrence and mortality between the groups.
The incidence rate (138.6/10,000 vs. 192.4/10,000 person-years), and risk of osteoporotic fractures (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.61-0.97; p = 0.024) were lower in the SERM + VitD group than in the SERMs group. Analysis for specific fractures showed a lower hazard of hip fracture in the SERM + VitD group (HR, 0.25; 95% CI, 0.09-0.71; p = 0.009). No difference was observed between the groups regarding mortality.
The risk of osteoporotic fractures, especially hip fractures, was lower in the SERM + VitD group than in the SERMs group. Therefore, the composite agent of SERMs and vitamin D can be considered as a viable option for postmenopausal women with a relatively low fracture risk.
通过对全国健康索赔数据的分析，与单独使用选择性雌激素受体调节剂（SERMs）相比，在年龄≥50 岁的骨质疏松症女性中，使用 SERMs 和维生素 D 的复合制剂（SERM+VitD）治疗可更好地降低骨质疏松性骨折和髋部骨折的风险。
本研究比较了 SERM 和维生素 D 的复合制剂（SERM+VitD）与单独使用 SERMs 治疗年龄≥50 岁女性预防骨折和降低死亡率的潜力。
使用韩国国家健康保险服务数据库 2017-2019 年的数据，对 SERM+VitD 和 SERMs 治疗后的骨质疏松性骨折（椎体、髋部、腕部或肱骨骨折）和全因死亡的发生率进行了描述。参与者被分为两组（SERM+VitD 组与 SERMs 组）。排除和倾向评分匹配后，每组纳入 2885 例患者进行分析。比较两组骨折发生率。使用 Kaplan-Meier 曲线比较死亡率。使用 Cox 比例风险回归分析比较两组骨折发生和死亡风险。
SERM+VitD 组的发生率（138.6/10000 人年与 192.4/10000 人年）和骨质疏松性骨折风险（风险比[HR]，0.77；95%置信区间[CI]，0.61-0.97；p=0.024）均低于 SERMs 组。对特定骨折的分析显示，SERM+VitD 组髋部骨折的风险较低（HR，0.25；95%CI，0.09-0.71；p=0.009）。两组间死亡率无差异。
与 SERMs 组相比，SERM+VitD 组骨质疏松性骨折，尤其是髋部骨折的风险较低。因此，SERM 和维生素 D 的复合制剂可作为骨折风险相对较低的绝经后女性的一种可行选择。
