Randomized active and placebo-controlled endoscopy study of a novel protected formulation of oral alendronate.

Digestive Diseases and Sciences
John K MarshallC James

Abstract

Although generally well tolerated, oral aminobisphosphonates have been associated with sporadic cases of severe esophageal injury attributed to pill contact. A novel protected formulation of oral alendronate uses an inert cylindrical shell to prevent mucosal contact with intact tablets. An active and placebo-controlled endoscopy study was undertaken to assess mucosal injury associated with this protected formulation. Healthy volunteers with normal baseline endoscopy were randomly assigned to receive protected alendronate 70 mg/day, standard alendronate 70 mg/day, or placebo for 14 days. Endoscopy was repeated on days 8 and 15. Of 78 subjects, 30 received protected alendronate, 28 received standard alendronate, and 20 received placebo. Mean gastric injury scores did not differ significantly among treatment groups. However, subjects on standard alendronate were more likely than those on protected alendronate to develop severe gastric injury, defined as Lanza score 3 or 4 (67.9% versus 33.3%, P=.009), and more likely to develop a gastric ulcer (21.4% versus 3.3%, P=.015). No differences in symptoms or adverse events were observed. In conclusion, a novel protected formulation of oral alendronate is less likely than standard alendro...Continue Reading

References

Oct 3, 1996·The New England Journal of Medicine·P C de GroenK K Wang
Nov 9, 2000·Alimentary Pharmacology & Therapeutics·J K MarshallR H Hunt
Nov 28, 2001·The American Journal of Gastroenterology·G Famularo, C De Simone
Aug 9, 2003·Expert Opinion on Drug Safety·John K Marshall

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Citations

Jul 10, 2013·Lasers in Medical Science·Jae-Yeol LeeSang-Hun Shin
Mar 24, 2011·Journal of Dental Research·R H KimN-H Park
Mar 4, 2010·Drug Delivery·Letícia CruzAdriana Raffin Pohlmann
Oct 29, 2014·Osteoporosis International : a Journal Established As Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA·N E MordenA N A Tosteson
Jul 16, 2008·Current Opinion in Gastroenterology·Antoine Geagea, Christophe Cellier
Jun 17, 2009·Current Opinion in Gastroenterology·Fabio PaceAlessandro Repici

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