Safety of oral bisphosphonates: controlled studies on alveolar bone.
OBJECTIVE
Osteoporosis and osteopenia are characterized by reductions in bone mass and may lead to skeletal fragility and fracture. The latest generation of oral bisphosphonate drugs, including alendronate and risendronate, has been approved for the prevention and treatment of osteoporosis. These medications are chemically absorbed into bone, decreasing osteoclast number and activity and thereby decreasing bone resorption. The purpose of this report is to present safety data from 2 controlled studies in patients receiving oral bisphosphonates.


METHODS
Study 1 tested the effect of alendronate, an inhibitor of bone resorption, on alveolar bone. A total of 335 patients (162 men and 173 women, aged 30 to 79 years) with moderate or severe periodontal disease were randomized to either placebo or 70 mg alendronate once weekly. Alveolar bone height and safety were assessed over a 2-year period. Study 2 was a longitudinal single-blind controlled design comparing implant success in 50 consecutive patients (210 implants), 25 patients who received bisphosphonate therapy and 25 age-matched control subjects. Implant success and safety, including incidence of osteonecrosis of the jaws (ONJ), was blindly assessed for at least 3 years.


RESULTS
In study 1, no cases of ONJ were observed in either treatment group. Furthermore, a trend toward lower incidences of infection and tooth loss was observed in the alendronate group. In study 2, no cases of ONJ were observed in either group, and implant success was greater than 99% in both groups.


CONCLUSIONS
On the basis of 2 controlled clinical studies, oral bisphosphonate usage was not associated with occurrence of ONJ.
Jeffcoat
Marjorie K
MK
University of Pennsylvania School of Dental Medicine, Philadelphia, Pennsylvania 19104, USA. jeffcoat@dental.upenn.edu
D000328:Adult; D000368:Aged; D016301:Alveolar Bone Loss / Q000188:drug therapy* / Q000517:prevention & control; D050071:Bone Density Conservation Agents / Q000009:adverse effects*; D003758:Dental Implantation, Endosseous; D004164:Diphosphonates / Q000009:adverse effects*; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D007571:Jaw Diseases / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged; D010020:Osteonecrosis / Q000139:chemically induced*
D050071:Bone Density Conservation Agents; D004164:Diphosphonates