Trial reportArchives of osteoporosis2024
Efficacy and safety of weekly liquid alendronate in Korean postmenopausal women with osteoporosis: a 12-month, multi-center, randomized trial.
Trial report in Archives of osteoporosis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05387200 (A Multi Center, Randomized, Open-label, Parallel, Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi Center, Randomized, Open-label, Parallel, Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis
Who cites it
1 citing paper in PubMed.
- Alendronate sodium demonstrates significant clinical advantages in treating osteoporosis secondary to severe fractures.American journal of translational research · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
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/
introductionAlendronate, 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.
methodsIn 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.
resultsAfter 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.
conclusionLiquid 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 registrationThe trial was registered with ClinicalTrials.gov (NCT05387200).
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