A team from Houston, Texas, USA, evaluated the upper gastrointestinal (GI) safety and tolerability of oral alendronate at a dose of 70 milligrams once weekly.
Alendronate at a dose of 10 mg daily has been shown in long-term clinical trials to be an effective treatment for postmenopausal osteoporosis.
However, a weekly dosing regimen of alendronate is preferred by both patients and physicians, as it has the potential to provide greater convenience and enhance compliance.
A total of 277 subjects (90 men) were randomized to 1 of 3 treatment groups. These were, 1) alendronate (70 mg once weekly) for 10 weeks (n = 126), 2) placebo (once weekly) for 10 weeks (n = 126), or 3) placebo (once weekly) for 10 weeks followed by aspirin (650 mg four times daily) for the last week as the positive control (n = 25).
Esophagogastroduodenoscopy was performed 5 to 7 days after the last dose of alendronate or matching placebo.
The mean gastric erosion scores (Lanza scale) were similar in subjects given alendronate and those given a placebo (0.32 vs 0.35, respectively). However, scores in both groups were significantly lower than in those given aspirin (3.09).
| Gastric erosion scores similar in alendronate and placebo groups.
| American Journal of Gastroenterology |
Endoscopic gastroduodenal ulcers occurred in no alendronate (0%), 2 placebo (2%), and 5 aspirin (24%) subjects.
The investigators found that the mean erosion scores in the esophagus and duodenum of alendronate and placebo subjects were also similar.
The incidences of upper GI symptoms were similar in the alendronate and placebo subjects, and did not suggest a relationship with endoscopic lesions.
Author F. Lanza, of the Houston Institute for Clinical Research, concluded on behalf of fellow colleagues, "Alendronate (70 mg once weekly) was not associated with any increase in endoscopic lesions in the upper GI tract relative to a placebo."