Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
Department of Digital Health and Epidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshidakonoe-Cho, Sakyo-Ku, Kyoto, 606-8501, Japan.
J Bone Miner Metab. 2023 Nov;41(6):890-900. doi: 10.1007/s00774-023-01470-7. Epub 2023 Oct 28.
Eldecalcitol (ELD) is an active vitamin D analog (AVD) commonly used to treat osteoporosis in Japan. Although routine monitoring of serum calcium levels during ELD therapy is recommended, little is known about the actual frequency and determinants of monitoring.
This was a descriptive cohort study using a Japanese electronic medical records database. We identified osteoporosis patients who initiated treatment with ELD or other AVDs (alfacalcidol and calcitriol) between April 1, 2011 and September 10, 2021. The index date for cohort entry was the first prescription date of ELD or other AVDs. The frequency of serum calcium monitoring was evaluated every 6 months. Determinants of serum calcium monitoring were identified using multivariable logistic regression models. We also calculated the incidence of hypercalcemia and the frequency of serum calcium monitoring within 6 months before hypercalcemia.
We identified 12,671 ELD users and 7867 other AVD users. Within 6 months after cohort entry, 45.9% of ELD users and 58.7% of other AVD users underwent serum calcium monitoring. Female sex, no use of systemic corticosteroids, moderate-to-good renal function, treatment in smaller hospitals, and treatment in orthopedic surgery departments were associated with a lower likelihood of receiving serum calcium monitoring during ELD therapy. The incidence of hypercalcemia among ELD users was 6.36 per 100 person-years, with 20.6% of cases not receiving serum calcium monitoring before hypercalcemia.
Our findings suggest that serum calcium monitoring is not given adequate attention during ELD therapy in routine clinical practice.
艾地骨化醇(ELD)是一种常用于日本治疗骨质疏松症的活性维生素 D 类似物(AVD)。尽管在 ELD 治疗期间建议常规监测血清钙水平,但对监测的实际频率和决定因素知之甚少。
这是一项使用日本电子病历数据库的描述性队列研究。我们确定了 2011 年 4 月 1 日至 2021 年 9 月 10 日期间开始接受 ELD 或其他 AVD(阿尔法骨化醇和骨化三醇)治疗的骨质疏松症患者。队列入组的索引日期为 ELD 或其他 AVD 的首次处方日期。每 6 个月评估一次血清钙监测的频率。使用多变量逻辑回归模型确定血清钙监测的决定因素。我们还计算了高钙血症的发生率和高钙血症前 6 个月内血清钙监测的频率。
我们确定了 12671 名 ELD 用户和 7867 名其他 AVD 用户。在入组后 6 个月内,45.9%的 ELD 用户和 58.7%的其他 AVD 用户接受了血清钙监测。女性、未使用全身皮质类固醇、中重度肾功能、在较小的医院治疗以及在矫形外科部门治疗与接受 ELD 治疗时更不可能进行血清钙监测相关。ELD 用户的高钙血症发生率为每 100 人年 6.36 例,其中 20.6%的病例在高钙血症前未接受血清钙监测。
我们的研究结果表明,在常规临床实践中,ELD 治疗期间对血清钙监测的重视程度不够。