Background Periodontal disease, the leading cause of tooth loss in adults, is a chronic inflammatory process which leads to a local imbalance between bone formation and bone resorption. Alendronate sodium (ALN) is a potent and selective inhibitor of osteoclastic bone resorption used for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal osteoporotic women, ALN 70 mg once weekly has demonstrated efficacy comparable to those of ALN 10 mg daily and very good safety and tolerability. However, there has been no direct comparison between ALN 70 mg once weekly and placebo.
Methods To further investigate the safety profile of once weekly ALN, as well as efficacy in periodontal disease, we are conducting a randomised, placebo-controlled, multicenter, 2-year study. Three-hundred and thirty-five patients aged 30 to 79 with periodontal disease were randomised to either placebo (PBO) or ALN 70 mg once weekly.
Results The overall and upper gastrointestinal (GI) safety and tolerability profile of ALN after one year of treatment was very favourable compared to placebo.
Conclusion In summary, 1-year data show that ALN 70 mg once weekly was very well tolerated in men and women with moderate to severe periodontal disease.
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