Alendronate is a bisphosphonate that has been shown to increase bone mineral density and to decrease the incidence of vertebral and non-vertebral fractures. Once weekly dosing of 70 mg alendronate was demonstrated previously (Schnitzer et al. Aging 12:1-12, 2000) to be as efficacious as the 10 mg daily dose. The purpose of the current study was to determine if the once weekly dose of 70 mg of alendronate would reduce esophageal irritation compared to once daily dosing.

Results: Two treatment groups were compared, alendronate 70 mg once weekly (OW) (n=519) and alendronate 10 mg daily (D). A similar incidence of overall upper GI events was noted in both groups (23.5% D versus 22.4% OW). The incidence of esophageal adverse events (AEs) and gastro-duodenal AEs were 1.9% D vs. 0.8% OW and 1.9% D vs. 0.6% OW, respectively (p not significant). The occurrence of serious upper GI events was reduced in patients receiving the once weekly dose of 70 mg (0%) compared to patients receiving the daily dose of 10 mg (1.4%), p 0.01. There was no difference in the incidence of upper GI events between the two groups in patients who had a previous history of upper GI disease or who were taking NSAIDs concurrently.

These data demonstrate that the once weekly dose of 70 mg of alendronate is well tolerated and causes a reduced number of serious upper GI events when compared to the 10 mg daily dose.

Editorial Comment: These data demonstrate a lower incidence of serious upper GI events with once weekly dosing of alendronate, but overall upper GI events were not significantly different between the two dosing regimens.

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