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A 24-month study to determine the effectiveness of MK-0217 in reducing alveolar bone loss in men and women with moderate or severe periodontal disease, in the absence of scaling and root planing

PI: Roy C. Page, D.D.S., Ph.D., Professor of Periodontics, Director RCDRC, Associate Dean, School of Dentistry, and Professor of Pathology, School of Medicine, University of Washington

This study aims to determine if treatment with oral Alendronate Sodium (MK-2l7, Fossamax) 70 mg once per week for up to two years is safe and effective in reducing the bone loss around teeth caused by periodontal disease in adult men and women.

Periodontitis is an infection around the necks of the teeth that results in destruction of the attachment of the gums to the teeth and resorption of the alveolar bone around the roots. Periodontitis is a major cause of tooth loss. Agents that reduce osteoclast activity could theoretically reduce and prevent alveolar bone loss. Alendronate sodium is approved for the prevention and treatment of osteoporosis for treatment of Padget¹s disease. This is a multicenter, randomized, double blind, placebo-controlled 24-month study with 6- and l2-month interim analyses to demonstrate the safety and efficacy of the drug. 300 men and women 30 years of age and older with moderate to severe periodontitis were enrolled in l2 centers through out the U.S. 70 mg of drug is being administered once per week for 24 months. Clinical and laboratory tests including serum chemistry, urinalysis, and hematology are used to assess drug safety. Attachment level and alveolar bone status assessed by digital subtraction radiography are used as outcome measures of effectiveness.

A total of 26 patients were enrolled at RCDRC. Two patients have discontinued participation in the study. We are currently conducting visit number 5 in a total of l0 visits. The study is therefore about one-half complete. No results are currently available to report. If the drug is safe and effective at preventing and reducing alveolar bone loss, an entirely new approach to prevention and treatment of periodontitis in adults will become available.

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