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Randomized Controlled Trial
, 28 (6), 694-700

Endoscopic Comparison of Alendronate Alone and the Enteric-Coated Alendronate With Calcitriol Combination in Postmenopausal Korean Females

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Randomized Controlled Trial

Endoscopic Comparison of Alendronate Alone and the Enteric-Coated Alendronate With Calcitriol Combination in Postmenopausal Korean Females

Ji Oh Mok et al. Korean J Intern Med.

Abstract

Background/aims: This study was performed to compare the mucosal findings after esophagogastroduodenoscopy in two groups before and after the use of alendronate only and following administration of the enteric-coated alendronate (5 mg) and calcitriol (0.5 µg) combined drug (Maxmarvil, Yuyu Co.).

Methods: The study population consisted of 33 postmenopausal healthy female volunteers, aged 50 to 70 years (mean age, 58 ± 5) without gastrointestinal symptoms and with normal baseline endoscopic findings. Esophagogastroduodenoscopy was performed at baseline and was repeated 2 weeks later after daily intake of Maxmarvil (n = 17 subjects) or alendronate only (n = 16 subjects). Mucosal injury scores were reported by an endoscopist after 2 weeks of treatment with each medication schedule.

Results: Esophageal mucosal injuries developed in two of 16 subjects in the alendronate only group and 0 of 17 in the Maxmarvil group. Gastric mucosal injuries developed in eight subjects in the alendronate group and four subjects in the Maxmarvil group; this difference was statistically significant.

Conclusions: The mucosal damage scores for the alendronate group (total score 24) were significantly higher than those for the Maxmarvil group (total score 9) in the esophagus and stomach. Therefore, this study suggested that enteric-coated Maxmarvil is less harmful to gastrointestinal mucosa than alendronate, and may improve the tolerability of osteoporosis medication in clinical practice.

Keywords: Alendronate; Osteoporosis; Safety.

Conflict of interest statement

No potential conflict of interest relevant to this article is reported.

Figures

Figure 1
Figure 1
Patients data for the Maxmarvil and alendronate treatment study.

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