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

Abstract

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).