Osteonecrosis of the jaw was a rare complication among older postmenopausal women with osteoporosis treated with denosumab for at least 3 years, despite 45% of women undergoing an invasive oral procedure while receiving treatment, according to findings published in The Journal of Clinical Endocrinology & Metabolism.
Researchers conducted an in-depth analysis of the FREEDOM Extension trial, a 7-year open-label study of denosumab (Prolia, Amgen). After 3 years of receiving the active drug or placebo, 0.68% of women who reported undergoing an oral procedure during the trial experienced an adjudicated case of osteonecrosis of the jaw, vs. 0.05% of women who did not undergo an oral procedure.
“This is an issue that causes anxiety to dental care providers and to patients,” Nelson B. Watts, MD, director of Mercy Health Osteoporosis and Bone Health Services in Cincinnati, told Endocrine Today. “I think the anxiety is misplaced and is due to lack of information. I hope our study will help with this.”
Watts and colleagues analyzed data from 3,591 postmenopausal women aged 60 to 90 years enrolled in FREEDOM Extension (60 mg denosumab every 6 months after 3 years of active drug or placebo) who completed questionnaires during extension year 3 regarding oral procedures and events (6 years after the start of FREEDOM). Participants reported whether they had a tooth extraction, natural tooth loss, dental implant placement or scaling/root planning during the first 2.5 years of the extension phase. The questionnaire was repeated every 6 months until end of study. Any reported cases of osteonecrosis of the jaw were verified via medical records and sent for independent expert adjudication. A positively identified case was defined as exposed alveolar or palatal bone in the oral cavity that did not heal after appropriate care by 8 weeks in someone without prior history of radiation to the head, face or mouth.
Among women who completed the survey, 1,621 (45.1%) reported at least one invasive oral procedure, with reported incidence of oral procedures similar between long-term denosumab and crossover groups, according to researchers.
The researchers identified 13 positively adjudicated cases of osteonecrosis of the jaw, including one in a woman who did not complete the survey (six cases in crossover denosumab participants; seven in long-term denosumab participants). The overall incidence over 7 years was 0.68% among women reporting invasive oral procedures and 0.05% in women reporting no invasive oral procedures. Of the 12 cases of osteonecrosis of the jaw with survey results, 10 resolved with treatment, one was ongoing at the end of study and one outcome was unknown due to study withdrawal.
Of eight women who continued to receive denosumab after the onset of osteonecrosis of the jaw, seven had lesions that resolved and one had an ongoing lesion at the end of study, according to researchers.
“My hope is our study will help patients and oral care providers be better informed about the low risk of [osteonecrosis of the jaw] compared to the fracture prevention benefits of antiresorptive therapy in women with postmenopausal osteoporosis,” Watts said in a press release. – by Regina Schaffer
For more information:
Nelson B. Watts, MD, can be reached at Mercy Health Osteoporosis and Bone Health Services, 4760 E. Galbraith Road, Suite 212, Cincinnati, OH 45236; email: email@example.com.
Disclosures: Amgen funded this study. Watts reports he has served as a consultant for AbbVie, Amgen, Radius and Sanofi, and received speaking fees from Amgen and Radius. Please see the study for the other authors’ relevant financial disclosures.