Are women with osteoporosis treated with denosumab at risk of severe COVID-19?
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RESEARCH LETTER
Are women with osteoporosis treated with denosumab at risk of severe COVID-19? Anna Maria Formenti1 Erika Pedone1 Luigi di Filippo1 Fabio Massimo Ulivieri1 Andrea Giustina ●
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Received: 11 July 2020 / Accepted: 11 September 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
Coronavirus disease 2019 (COVID-19), is a primarily respiratory infection [1] which not infrequently leads to a severe syndrome requiring hospitalization and assisted ventilation with high lethality [2] also causing very frequently and in some instances severe hypocalcemia [3, 4]. According to the last available age-related analysis of the Italian “Istituto Superiore di Sanità” (ISS) on June 26 2020, median age of the almost 240.000 confirmed cases of the SARS-CoV-2 infection was 61 years and almost 130.000 of them were females (54.2%). Specifically, about two thirds of the females who were proven to be infected were older than 50 years. Moreover, in a subgroup analysis, two thirds of the patients had symptomatic infection ranging from very mild/mild (48%) to severe (18%) infection [5]. Osteoporosis is a systemic skeletal disorder characterized by bone strength decrease and altered skeletal microarchitecture leading to an increased risk of vertebral and hip fractures [6]. In a cross-sectional, multicenter, cohort study evaluating 3247 postmenopausal women aged ≥50 and older in Italy the prevalence of osteoporosis, as assessed by BMD and NBHA criteria, was 36.6% and 57%, respectively [7]. Several pharmacological (antiresorptive such as bisphosphonates and denosumab and anabolic as teriparatide) and non-pharmacological (vitamin D and calcium) treatment options are available and highly effective in preventing fragility fractures for postmenopausal and other forms of osteoporosis [6, 8–10]. Denosumab is a human monoclonal antibody (IgG2 immunoglobulin isotype) which binding with high affinity and specificity to RANKL and induces rapid and profound inhibition of bone resorption for 6 months. Features
* Andrea Giustina [email protected] 1
Institute of Endocrine and Metabolic Sciences, Vita-Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan, Italy
distinguishing denosumab from bisphosphonates are higher antiresorptive potency, rapid reversibility of antiresorptive effect, and better safety profile in patients with impaired renal function [8]. Denosumab has proven to be effective and is currently indicated in postmenopausal, glucocorticoid-, aromatase inhibitor-, and androgen deprivationinduced osteoporosis [11]. Another distinctive feature of denosumab as compared to bisphosphonates, is its possible action as an immune system modulator. In fact, risk of infections in denosumab users is a potential clinical concern [8]. Interestingly, in a recent metaanalysis [12] it was evaluated the risk of severe infections as side effects (SAEi) of treatment with denosumab. In this meta-analysis of 33 RCTs including 22.253 patients higher incidence
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