Korean J Intern Med.  2013 Nov;28(6):694-700. 10.3904/kjim.2013.28.6.694.

Endoscopic comparison of alendronate alone and the enteric-coated alendronate with calcitriol combination in postmenopausal Korean females

• Mok JO
• Jung CH
• Kim CH
• Ryu CB
• Kim YJ
• Kim SJ
• Park HK
• Suh KI
• Yoo MH
• Byun DW

• KMID: 1780130
• DOI: http://doi.org/10.3904/kjim.2013.28.6.694

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 microg) 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.

Keyword

Alendronate; Safety; Osteoporosis

MeSH Terms

Administration, Oral
Age Factors
Aged
Alendronate/administration & dosage/*adverse effects
Bone Density Conservation Agents/administration & dosage/*adverse effects
Calcitriol/administration & dosage/*adverse effects
Drug Combinations
*Endoscopy, Digestive System
Esophagus/*drug effects/pathology
Female
Gastric Mucosa/*drug effects/pathology
Humans
Middle Aged
*Postmenopause
Predictive Value of Tests
Republic of Korea
Sex Factors
Tablets, Enteric-Coated
Time Factors
Treatment Outcome
Vitamins/administration & dosage/*adverse effects
Alendronate
Bone Density Conservation Agents
Calcitriol
Drug Combinations
Tablets, Enteric-Coated
Vitamins