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Bone Drug Improves Results of Jaw Surgery
  By Michael Smith, North American Correspondent, MedPage Today
Published: October 16, 2010
Action Points
* Explain to interested patients that a small study found improved increase in periodontal bone thickness in patients who underwent periodontal surgery and received teriparatide compared with those who took placebo.
* Note that secondary endpoints of depth of probing and clinical tooth attachment also improved in those receiving teriparatide.
TORONTO -- A short course of the osteoporosis drug teriparatide (Forteo) significantly improved outcomes of periodontal surgery, researchers found.
In a small randomized placebo-controlled trial, periodontal patients getting teriparatide had nearly 10 times the gain in bone after a year as did placebo patients, Laurie McCauley, DDS, PhD, and colleagues at the University of Michigan Ann Arbor reported here.
Patients on the drug also had significant clinical improvements compared with placebo patients, including a greater reduction in probing depth and a greater gain in clinical attachment levels, according to the study presented at the American Society for Bone and Mineral Research meeting and published simultaneously online by the New England Journal of Medicine.
The drug, which consists of the first 34 amino acids of parathyroid hormone, has anabolic effects on bone, and McCauley said the study suggests it may be a useful tool in patients with severe periodontitis who need surgery.
The researchers enrolled 40 patients with severe chronic periodontitis, who were randomly assigned to daily injections of 20 micrograms of teriparatide or placebo for six weeks. All participants also took 1,000 milligrams of oral calcium and 800 IU of vitamin D.
The treatment began three days before surgery and patients were followed for a year, with radiographic linear measurement of alveolar bone level at 12 months as the primary outcome. Clinical variables, such as probing depth, were secondary outcomes.
After standard periodontic surgery at a single site in each patient's mouth, the researchers found:
* Patients getting teriparatide had an average linear gain in bone of 29%, compared with 3% for those getting placebo (P<0.001).
* In patients getting the drug, probing depth was reduced by an average of 2.42 millimeters, compared with 1.32 millimeters, on average, among the placebo patients. The difference -- 33% versus 20% -- was significant at P=0.02.
* Teriparatide patients had a 22% average gain in clinical attachment level, compared with 7% average among those getting the placebo. The difference -- 1.58 millimeters versus 0.42 -- was also significant at P=0.02.
There were no differences in adverse events between the arms, but the researchers cautioned that the small size of the study meant that rare events would not have been detected. Because the study was small, they added, the results should be interpreted with caution.
Indeed, for that reason, the study provides only "preliminary evidence" that a drug that stimulates bone formation might yield additional benefit over standard care in periodontal surgery, according to Andrew Grey, MD, of the University of Auckland in Auckland, New Zealand.
Writing in an accompanying editorial, Grey argued that several questions remain to be answered, including:
* How durable is the effect?
* What is the optimal dose?
* Does teriparatide affect such things as tooth loss and the need for further surgery?
* Can the same benefits be obtained with antiresorptive agents, which are cheaper?
Longer and larger trials will be needed to answer those questions, Grey argued.
In a related case report in the journal, two Australian researchers reported that teriparatide speedily cured osteonecrosis of the jaw in an 88-year-old woman.
After a tooth extraction, the woman had a 12-month history of pain, suppuration, and failed healing of a mandibular socket, according to Ada Cheung, MBBS, and Ego Seeman, MD, of Austin Health in Melbourne.
The woman had been taking 70 milligrams of alendronate (Fosamax) weekly for osteoporosis, as well as prednisone for asthma. She was treated off-label with 20 micrograms a day of teriparatide for eight weeks, and her symptoms resolved, Cheung and Seeman reported.
The report, combined with two similar case reports earlier, suggests that a randomized controlled trial might be informative, they concluded.
Unfortunately, Grey commented, that is likely to be difficult because the incidence of jaw osteonecrosis is too low, at least among patients who do not have cancer.
The study had support from Eli Lilly, the American Academy of Periodontology Foundation Tarrson Regeneration Scholarship, and the NIH. McCauley reported financial links with Eli Lilly, which provided study drug and placebo.
Grey reported no relevant potential conflicts.
Cheung reported no conflicts, but Seeman reported financial links with Eli Lilly, Amgen, sanofi-aventis, Merck Sharpe & Dohme, Novartis, and Proctor & Gamble.
Primary source: New England Journal of Medicine Source reference: Bashutski JD, et al "Teriparatide and osseous regeneration in the oral cavity" N Engl J Med 2010.
Additional source: New England Journal of Medicine
Source reference:
Grey A "Teriparatide for bone loss in the jaw" N Engl J Med 2010.
Additional source: New England Journal of Medicine
Source reference:
Cheung A, Seeman E "Teriparatide therapy for alendronate-associated
osteonecrosis of the jaw" N Engl J Med 2010.
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