Medical Science Department, Medical Affairs Division, Chugai Pharmaceutical Co., Ltd, 1-1 Nihonbashi-Muromachi, 2-Chome, Chuo-ku, Tokyo, 103-8324, Japan.
Real World Data Science Department, Drug Safety Division, Chugai Pharmaceutical Co., Ltd, 1-1 Nihonbashi-Muromachi, 2-Chome, Chuo-ku, Tokyo, 103-8324, Japan.
J Bone Miner Metab. 2019 Mar;37(2):292-300. doi: 10.1007/s00774-018-0915-2. Epub 2018 Mar 12.
We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P < 0.0001) than at baseline, and levels of the bone turnover markers BAP and TRACP-5b were reduced (-14.64%; P = 0.0009, and - 29.51%; P < 0.0001, respectively). In conclusion, the safety and effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.
我们进行了一项上市后观察性研究，以调查在日本临床环境中艾地骨化醇治疗骨质疏松症的安全性和有效性。女性患者的观察期为 12 个月，男性患者为 36 个月。女性患者的最终结果已经发表。本文报告了男性患者的最终结果。共纳入 470 例男性骨质疏松症患者。安全性分析集包括 431 例患者（平均年龄 76.8 岁；平均随访时间 631.0±450.3 天），175 例患者在整个 3 年观察期间持续接受治疗。28 例（6.49%）报告了药物不良反应（ADR）；最常见的 ADR 是高钙血症（1.16%）和肾功能损害（1.16%）。报告了 5 例严重 ADR（1.16%）。整个观察期间，血清钙均处于正常范围内。通过 Kaplan-Meier 分析估计，36 个月时新椎体和非椎体骨折的累积发生率分别为 10.23%和 4.06%。末次观察时，腰椎骨密度较基线时平均升高 3.49%（P<0.0001），骨转换标志物 BAP 和 TRACP-5b 水平分别降低（-14.64%；P=0.0009 和-29.51%；P<0.0001）。总之，在临床实践中证实了艾地骨化醇治疗日本男性骨质疏松症患者的安全性和有效性。在治疗前后均需密切监测血清钙和估计肾小球滤过率，以最大限度地降低高钙血症和肾功能损害的风险，同时最大限度地提高艾地骨化醇的疗效。
