Oral Bisphosphonate Use Linked to Osteonecrosis of the Jaw

Four percent of patients at dental school with history of oral bisphosphonate use have jaw problem

11 jan 2009-- Osteonecrosis of the jaw may be more common in people who have used the oral bisphosphonate Fosamax than data has previously reported, especially following tooth extraction, according to an article published online Jan. 1 in the Journal of the American Dental Association.

Parish P. Sedghizadeh, D.D.S., of the University of Southern California in Los Angeles, and colleagues analyzed the USC School of Dentistry's electronic records system to identify patients with a history of Fosamax use, as well as patients on the drug being managed for active osteonecrosis of the jaw.

The authors found 208 patients with a history of Fosamax use. Of these, nine had active osteonecrosis of the jaw, which represented roughly 4 percent of Fosamax-using patients. Patients' ages ranged from 63 to 80; all were females who took the drug for at least 12 months for osteoporosis. All cases occurred after tooth extraction or denture trauma with exposure of bone, the report indicates.

"Current data like ours suggesting a risk of osteonecrosis of the jaw in oral bisphosphonate users has prompted us to actively screen every patient who comes to the school with updated consent and patient medical history forms reflecting the need for increased awareness and early risk or disease assessment. We have also updated our consent for dental surgery (e.g. extractions) with the American Dental Association recommended statement: 'Because you are taking a type of drug called bisphosphonate, you may be at risk of developing osteonecrosis (bone death) of the jaw and certain dental treatment may increase that risk,'" the authors write.

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FDA Approves Once-A-Year Infusion for Osteoporosis

EAST HANOVER, N.J., Aug. 20. -- The FDA has approved a once-yearly formulation of zoledronic acid (Reclast) for osteoporosis in postmenopausal women, Novartis announced.
The drug, administered in a single 15-minute-long intravenous infusion, was already approved for treatment of Paget's disease.
Novartis said the once-a-year dosing schedule allows clinicians to guarantee that women were receiving recommended therapy in a way that "will have a positive impact on the management of this potentially devastating condition."
In a three-year randomized, double-blind, placebo-controlled phase III trial of 7,765 women, the once yearly treatment reduced vertebral fractures by 70%, hip fractures by 41%, and nonvertebral factures by 25%, according to findings reported in the New England Journal of Medicine.
Those results were comparable to oral weekly or monthly bisphosphonate treatment.
However, serious atrial fibrillation occurred more frequently in the zoledronic acid group (in 50 versus 20 patients, P<0.001). Zoledronic acid is contraindicated in patients with hypocalcemia. The once-a-year formulation contains the same active ingredients as Zometa, so the drug should not be given to patients already being treated with Zometa, said Novartis.
It should not be used in pregnancy because of possible harm to the fetus and is not recommended for patients with creatinine clearance of <35mL/min.
The most common side effects associated with zoledronic acid are fever, musculoskeletal pain or joint pain, flu-like symptoms, and headache. Symptoms usually occur within three days of infusion and resolve in three to four days, but may last for two weeks.
Because osteonecrosis of the jaw has been reported in postmenopausal women taking bisphosphonates, a routine oral examination is recommended before initiating zoledronic acid infusion.