Periodontal disease is characterized by
periodontal bone loss. For this reason, we conducted a study to test the effect of
alendronate (ALN), an inhibitor of
bone resorption, on alveolar bone mass. A total of 335 patients with
periodontal disease (men = 162, women = 173), aged 30 to 79, were randomized to either placebo or ALN 70 mg once weekly. All patients received prophylaxis at baseline, and at 6, 12, and 18 months. Smokers accounted for 62% of patients, and 71% of the patients had severe
periodontal disease. The primary efficacy endpoint was the change in
alveolar bone loss (ABL). When all subjects were analyzed, 2 years of treatment with
alendronate 70 mg once weekly did not significantly change either ABL or alveolar bone density (ABD) relative to placebo. However, in the subgroup of patients with low mandibular bone mineral density (BMD) at baseline,
alendronate significantly reduced bone loss relative to placebo (p < 0.01). No such effect was seen in patients with normal baseline mandibular BMD. The overall and upper gastrointestinal safety and tolerability profile of
alendronate after 2 years of treatment was very favorable compared to placebo. No cases of
osteonecrosis of the jaw were observed. In summary, in patients with
periodontal disease receiving prophylaxis,
alendronate 70 mg once weekly was well tolerated, but did not have a detectable effect on
alveolar bone loss, except in those patients with low mandibular BMD at baseline.