A randomized controlled trial to assess alendronate-associated injury of the upper gastrointestinal tract

Background: Aminobisphosphonates are recommended for postmenopausal osteopo rosis but have been associated with injury to the upper gastrointestinal tr act. Aim: To conduct a randomized controlled trial, to assess the endoscopic dam age caused by alendronate and its effect on gastric mucosal prostaglandin s ynthesis. Methods: Seventy-six healthy volunteers age 40-60 years, with normal baseli ne endoscopy were randomly assigned to treatment with: (A) ASA 650 mg q.d.s .; (B) alendronate 10 mg o.d.; or (C) placebo o.d. for 14 days. Mucosal inj ury scores on day 14 of treatment were reported by a blinded endoscopist. G astric biopsies were analysed for prostaglandin E-2 (PGE(2)) concentration by radioimmunoassay. Results: Oesophageal injury did not differ among treatment groups. Gastric ulcers developed in five out of 26 subjects given ASA, two out of 25 given alendronate, and none of 25 given placebo. The mucosal damage scores for th e alendronate group exceeded those for the placebo group in the gastric bod y but not at other sites. Injury scores for ASA exceeded those for placebo in the duodenum, antrum, body, and fundus. The mean change in log(10)[PGE(2 )] (ng/mg protein) was - 0.07 for placebo, - 0.80 for ASA, and + 0.62 for a lendronate (differences not significant). Conclusions: Alendronate is associated with injury and ulceration of the ga stric mucosa. This effect was not associated with any significant change in gastric mucosal PGE(2) levels.