Department of Internal Medicine, Severance Hospital, Endocrine Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-Ro, Seodaemun-gu, Seoul, 03722, Republic of Korea.
Department of Endocrinology and Metabolism, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.
Arch Osteoporos. 2024 Nov 26;19(1):119. doi: 10.1007/s11657-024-01480-6.
This study compared liquid and tablet forms of alendronate for osteoporosis treatment. After 12 months, both forms increased bone density to a similar degree with no significant differences in side effects. New low-volume liquid alendronate is as effective as tablets, offering an alternative treatment option for postmenopausal women with osteoporosis.
PURPOSE/INTRODUCTION: Alendronate, despite its significant efficacy, poses challenges due to complex administration protocols and patient compliance issues, underscoring the need for various formulations. This study compared the efficacy and safety of once-weekly low-volume liquid alendronate sodium trihydrate (ALN-S), an oral solution, to once-weekly alendronate sodium (ALN-T), an oral tablet, in Korean postmenopausal women with osteoporosis.
In a 12-month, multi-center, prospective, randomized, open-labeled, parallel trial conducted at two hospitals in Korea, 170 patients were randomized to alendronate solution (ALN-S) (N = 85) or alendronate tablet (ALN-T) (N = 85) groups. The bone mineral density (BMD) of the lumbar spine (LS), femoral neck (FN), and total hip (TH) was measured at baseline and after 12 months. Bone turnover markers (BTMs) were assessed at baseline, 6, and 12 months. The primary outcome was the percentage change in BMD of the LS, evaluated for non-inferiority.
After 12 months, both ALN-S and ALN-T groups exhibited a significant increase in LS, FN, and TH BMD, with no significant intergroup differences (ALN-S: LS 5.0 ± 0.6%, FN 1.8 ± 0.6%, TH 2.2 ± 0.5%; ALN-T: LS 5.2 ± 0.6%, FN 1.6 ± 0.6%, TH 1.8 ± 0.5%). ALN-S was found to be non-inferior to ALN-T for BMD change at LS (treatment difference: - 0.22%, 95% CI: - 1.84 to 1.40%), excluding the predefined non-inferiority margin of - 2.29%. Changes in BTMs did not differ significantly between groups. The frequency of adverse events was similar between groups.
Liquid alendronate was non-inferior to tablet alendronate in increasing BMD in Korean postmenopausal women with osteoporosis, presenting a viable alternative when the tablet form is limited in various clinical scenarios.
The trial was registered with ClinicalTrials.gov (NCT05387200).
目的/引言：尽管阿仑膦酸钠具有显著的疗效，但由于其复杂的给药方案和患者顺应性问题，仍存在挑战，这凸显了各种制剂的必要性。本研究比较了每周一次低容量的阿仑膦酸钠三水合物口服液（ALN-S）和每周一次的阿仑膦酸钠片（ALN-T）在韩国绝经后骨质疏松症女性中的疗效和安全性。
在韩国两家医院进行的一项为期 12 个月的多中心、前瞻性、随机、开放标签、平行试验中，170 名患者被随机分配至阿仑膦酸钠溶液（ALN-S）（n=85）或阿仑膦酸钠片（ALN-T）（n=85）组。基线和 12 个月时测量腰椎（LS）、股骨颈（FN）和全髋（TH）的骨密度（BMD）。基线、6 个月和 12 个月时评估骨转换标志物（BTMs）。主要结局为 LS 的 BMD 百分比变化，评估非劣效性。
12 个月后，ALN-S 和 ALN-T 组 LS、FN 和 TH 的 BMD 均显著增加，组间无显著差异（ALN-S：LS 5.0±0.6%，FN 1.8±0.6%，TH 2.2±0.5%；ALN-T：LS 5.2±0.6%，FN 1.6±0.6%，TH 1.8±0.5%）。ALN-S 在 LS 的 BMD 变化方面被证明不劣于 ALN-T（治疗差异：-0.22%，95%CI：-1.84 至 1.40%），排除了预设的不劣效性边界-2.29%。组间 BTM 变化无显著差异。两组不良反应发生率相似。
在韩国绝经后骨质疏松症女性中，液体阿仑膦酸钠在增加 BMD 方面与片剂阿仑膦酸钠不劣效，在各种临床情况下片剂形式受到限制时提供了一种可行的替代方案。
该试验在 ClinicalTrials.gov 上注册（NCT05387200）。
