Studies that reported ulceration of the oral mucosa in patients who used alendronate were eligible for the review. Studies were required to show an association between the drug and the ulcer as a result of healing occurring after withdrawal of the drug or after changing the method of drug administration. Studies were excluded if they described osteonecrosis of the jaw as a result of alendronate or if the ulcers were not limited to the oral mucosa.
In the included studies, the average age of patients was 70 years (range 49 to 90 years) and 62% were women. Most had osteoporosis and all had systemic disease. About half of the patients had removable dentures. Seventy-three percent of patients used alendronate once a day at a dosage of 10mg per day, where reported; three patients used a dosage of 70mg per week. All patients except one were reported to misuse alendronate by sucking on tablets or keeping within the mouth for a long time. Duration of the oral ulcers ranged from two days to 12 months. The most common symptom was pain.
The authors did not state how many reviewers selected studies for the review.