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Invasive Oral Procedures and Events in Postmenopausal Women With Osteoporosis Treated With Denosumab for Up to 10 Years
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Invasive Oral Procedures and Events in Postmenopausal Women With Osteoporosis Treated With Denosumab for Up to 10 Years
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Journal Article
Invasive Oral Procedures and Events in Postmenopausal Women With Osteoporosis Treated With Denosumab for Up to 10 Years
2019
Overview
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.
Self-reported invasive OPEs were common in women treated with denosumab up to 10 years and were associated with increased ONJ incidence; however, the overall rate of ONJ was low.
Publisher
Endocrine Society,Oxford University Press
Subject
/ Bone Density Conservation Agents - adverse effects
/ Dental Implants - adverse effects
/ Female
/ Humans
/ Jaw
/ Orthognathic Surgical Procedures - adverse effects
/ Osteonecrosis - chemically induced
/ Osteonecrosis - epidemiology
/ Osteoporosis, Postmenopausal - drug therapy
/ Surgery
/ Teeth
