Invasive oral procedures and events in postmenopausal women with osteoporosis treated with denosumab for up to 10 years

Journal article


Watts, Nelson B., Grbic, John T., Binkley, Neil, Papapoulos, Socrates E., Butler, Peter W., Yin, Xiang, Tierney, Antoniette, Wagman, Rachel B. and McClung, Michael. (2019) Invasive oral procedures and events in postmenopausal women with osteoporosis treated with denosumab for up to 10 years. Journal of Clinical Endocrinology and Metabolism. 104(6), pp. 2443 - 2452. https://doi.org/10.1210/jc.2018-01965
AuthorsWatts, Nelson B., Grbic, John T., Binkley, Neil, Papapoulos, Socrates E., Butler, Peter W., Yin, Xiang, Tierney, Antoniette, Wagman, Rachel B. and McClung, Michael
Abstract

Context Antiresorptive therapy has been associated with osteonecrosis of the jaw (ONJ), an infrequent but potentially serious adverse event. Objective To assess information on invasive oral procedures and events (OPEs)—dental implants, tooth extraction, natural tooth loss, scaling/root planing, and jaw surgery—during the 7-year Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months (FREEDOM) Extension study and to present details of positively adjudicated ONJ cases. Design Randomized, double-blind, placebo-controlled, 3-year trial (FREEDOM) followed by 7 years of open-label denosumab (FREEDOM Extension). At Extension Year 3, women were asked to record their history of invasive OPEs since the start of the Extension to Year 2.5 and oral events in the prior 6 months. The questionnaire was then administered every 6 months until the end of the Extension. Setting Multicenter, multinational clinical trial. Patients Postmenopausal women with osteoporosis. Interventions Subcutaneous denosumab 60 mg or placebo every 6 months for 3 years, then 7 years of open-label denosumab. Main Outcome Measures Self-reports of OPEs and adjudicated cases of ONJ. Results Of respondents, 45.1% reported at least one invasive OPE. The exposure-adjusted ONJ rate in FREEDOM Extension was 5.2 per 10,000 person-years. ONJ incidence was higher in those reporting an OPE (0.68%) than not (0.05%). Conclusions Although invasive OPEs were common in these denosumab-treated women and were associated with an increased ONJ incidence, the overall rate of ONJ was low, and all cases with complete follow-up resolved with treatment.

Keywordsparathyroid; bone; and mineral metabolism
Year2019
JournalJournal of Clinical Endocrinology and Metabolism
Journal citation104 (6), pp. 2443 - 2452
PublisherOxford University Press
ISSN0021-972X
Digital Object Identifier (DOI)https://doi.org/10.1210/jc.2018-01965
Scopus EID2-s2.0-85065834457
Page range2443 - 2452
Research GroupMary MacKillop Institute for Health Research
Place of publicationUnited States of America
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