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. The Journal of Clinical Endocrinology and Metabolism. 104(6), pp. 2443 - 2452. https://doi.org/10.1210/jc.2018-01965
Authors | Watts, 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. |
Keywords | parathyroid; bone; and mineral metabolism |
Year | 2019 |
Journal | The Journal of Clinical Endocrinology and Metabolism |
Journal citation | 104 (6), pp. 2443 - 2452 |
Publisher | Oxford University Press |
ISSN | 0021-972X |
Digital Object Identifier (DOI) | https://doi.org/10.1210/jc.2018-01965 |
Scopus EID | 2-s2.0-85065834457 |
Page range | 2443 - 2452 |
Research Group | Mary MacKillop Institute for Health Research |
Publisher's version | File Access Level Controlled |
Place of publication | United States of America |
https://acuresearchbank.acu.edu.au/item/86v36/invasive-oral-procedures-and-events-in-postmenopausal-women-with-osteoporosis-treated-with-denosumab-for-up-to-10-years
Restricted files
Publisher's version
100
total views0
total downloads1
views this month0
downloads this month