Efficacy and safety of weekly liquid alendronate in Korean postmenopausal women with osteoporosis: a 12-month, multi-center, randomized trial

IF 3.1 3区医学 Q2 ENDOCRINOLOGY & METABOLISM Archives of Osteoporosis Pub Date : 2024-11-26 DOI:10.1007/s11657-024-01480-6

Seungjin Baek, Seong Hee Ahn, Namki Hong, Da Hea Seo, Seongbin Hong, Yumie Rhee

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Abstract

Summary

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.

Methods

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.

Results

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.

Conclusion

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.

Clinical trial registration

The trial was registered with ClinicalTrials.gov (NCT05387200).

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韩国绝经后骨质疏松症妇女每周服用液体阿仑膦酸钠的疗效和安全性：一项为期 12 个月的多中心随机试验

摘要这项研究比较了用于治疗骨质疏松症的阿仑膦酸钠液剂和片剂。12 个月后，两种剂型的骨密度增加程度相似，副作用无明显差异。新型低容量液态阿仑膦酸钠与片剂一样有效，为绝经后妇女骨质疏松症患者提供了另一种治疗选择。目的/简介阿仑膦酸钠尽管疗效显著，但由于给药方案复杂和患者依从性问题，给其治疗带来了挑战，这就凸显了对各种制剂的需求。本研究比较了在韩国绝经后骨质疏松症女性患者中，每周一次的低容量阿仑膦酸钠三水合物液体口服溶液（ALN-S）和每周一次的阿仑膦酸钠口服片剂（ALN-T）的疗效和安全性。方法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 名患者被随机分配到阿仑膦酸钠溶液（ALN-S）组（85 人）或阿仑膦酸钠片剂（ALN-T）组（85 人）。在基线和 12 个月后测量腰椎 (LS)、股骨颈 (FN) 和全髋 (TH) 的骨矿物质密度 (BMD)。在基线、6 个月和 12 个月时评估骨转换标志物 (BTM)。结果12个月后，ALN-S组和ALN-T组的LS、FN和TH BMD均显著增加，组间差异不显著（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 1.8 ± 0.6%，TH 2.2 ± 0.5%）：LS：5.2 ± 0.6%，FN：1.6 ± 0.6%，TH：1.8 ± 0.5%）。研究发现，在 LS 阶段，ALN-S 的 BMD 变化不劣于 ALN-T（治疗差异：- 0.22%，95% CI：- 1.84 至 1.40%），不包括预先确定的非劣效边际 - 2.29%。各组间的 BTM 变化无显著差异。结论液态阿仑膦酸钠在增加韩国绝经后骨质疏松症妇女的 BMD 方面不劣于片剂阿仑膦酸钠，在各种临床情况下，当片剂受到限制时，液态阿仑膦酸钠是一种可行的替代药物。临床试验注册该试验已在 ClinicalTrials.gov (NCT05387200) 上注册。

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来源期刊

Archives of Osteoporosis ENDOCRINOLOGY & METABOLISMORTHOPEDICS -ORTHOPEDICS

CiteScore

5.50

自引率

10.00%

发文量

133

期刊介绍： Archives of Osteoporosis is an international multidisciplinary journal which is a joint initiative of the International Osteoporosis Foundation and the National Osteoporosis Foundation of the USA. The journal will highlight the specificities of different regions around the world concerning epidemiology, reference values for bone density and bone metabolism, as well as clinical aspects of osteoporosis and other bone diseases.