Context: Intravenous aminobisphosphonates (N-BPs) can induce an acute phase reaction (APR) in up to 40% to 70% of first infusions, causing discomfort and often requiring intervention with analgesics or antipyretics. Objective: Our aim was to explore the risk factors of APR in a large sample of patients with Paget's disease of bone (PDB) and to assess the possible preventive effects of vitamin D administration. Methods: An observational analysis was performed in 330 patients with PDB at the time of N-BP infusion. Then, an interventional study was performed in 66 patients with active, untreated PDB to evaluate if vitamin D administration (oral cholecalciferol 50 000 IU/weekly for 8 weeks before infusion) may prevent APR. Results: In a retrospective study, APR occurred in 47.6% and 18.3% of naive or previously treated patients, respectively. Its prevalence progressively increased in relation to the severity of vitamin D deficiency, reaching 80.0% in patients with 25-hydroxyvitamin D (25OHD) levels below 10 ng/mL (relative risk (RR) = 3.7; 95% confidence interval (CI) 2.8-4.7, P < .0001), even in cases previously treated with N-BPs. Moreover, APR occurred more frequently in patients who experienced a previous APR (RR = 2.8; 95% CI 1.5-5.2; P < .001) or in carriers of SQSTM1 mutation (RR = 2.3; 95% CI 1.3-4.2; P = .005). In the interventional study, vitamin D supplementation prevented APR in most cases, equivalent to a RR of 0.31 (95% CI 0.14-0.67; P < .005) with respect to prevalence rates of the observational cohort. A similar trend was observed concerning the occurrence of hypocalcemia. Conclusions: The achievement of adequate 25OHD levels is recommended before N-BP infusion in order to minimize the risk of APR or hypocalcemia in PDB.

PREVENTIVE ROLE OF VITAMIN D SUPPLEMENTATION FOR ACUTE PHASE REACTION AFTER BISPHOSPHONATE INFUSION IN PAGET'S DISEASE / Merlotti, Daniela; Rendina, Domenico; Muscariello, Riccardo; Picchioni, Tommaso; Alessandri, Mario; De Filippo, Gianpaolo; Materozzi, Maria; Bianciardi, Simone; Franci, Maria Beatrice; Lucani, Barbara; Cenci, Simone; Strazzullo, Pasquale; Nuti, Ranuccio; Gennari, Luigi. - In: THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM. - ISSN 0021-972X. - 105:3(2020), pp. 466-476. [10.1210/clinem/dgz138]

PREVENTIVE ROLE OF VITAMIN D SUPPLEMENTATION FOR ACUTE PHASE REACTION AFTER BISPHOSPHONATE INFUSION IN PAGET'S DISEASE

Rendina, Domenico;Muscariello, Riccardo;Strazzullo, Pasquale;
2020

Abstract

Context: Intravenous aminobisphosphonates (N-BPs) can induce an acute phase reaction (APR) in up to 40% to 70% of first infusions, causing discomfort and often requiring intervention with analgesics or antipyretics. Objective: Our aim was to explore the risk factors of APR in a large sample of patients with Paget's disease of bone (PDB) and to assess the possible preventive effects of vitamin D administration. Methods: An observational analysis was performed in 330 patients with PDB at the time of N-BP infusion. Then, an interventional study was performed in 66 patients with active, untreated PDB to evaluate if vitamin D administration (oral cholecalciferol 50 000 IU/weekly for 8 weeks before infusion) may prevent APR. Results: In a retrospective study, APR occurred in 47.6% and 18.3% of naive or previously treated patients, respectively. Its prevalence progressively increased in relation to the severity of vitamin D deficiency, reaching 80.0% in patients with 25-hydroxyvitamin D (25OHD) levels below 10 ng/mL (relative risk (RR) = 3.7; 95% confidence interval (CI) 2.8-4.7, P < .0001), even in cases previously treated with N-BPs. Moreover, APR occurred more frequently in patients who experienced a previous APR (RR = 2.8; 95% CI 1.5-5.2; P < .001) or in carriers of SQSTM1 mutation (RR = 2.3; 95% CI 1.3-4.2; P = .005). In the interventional study, vitamin D supplementation prevented APR in most cases, equivalent to a RR of 0.31 (95% CI 0.14-0.67; P < .005) with respect to prevalence rates of the observational cohort. A similar trend was observed concerning the occurrence of hypocalcemia. Conclusions: The achievement of adequate 25OHD levels is recommended before N-BP infusion in order to minimize the risk of APR or hypocalcemia in PDB.
2020
PREVENTIVE ROLE OF VITAMIN D SUPPLEMENTATION FOR ACUTE PHASE REACTION AFTER BISPHOSPHONATE INFUSION IN PAGET'S DISEASE / Merlotti, Daniela; Rendina, Domenico; Muscariello, Riccardo; Picchioni, Tommaso; Alessandri, Mario; De Filippo, Gianpaolo; Materozzi, Maria; Bianciardi, Simone; Franci, Maria Beatrice; Lucani, Barbara; Cenci, Simone; Strazzullo, Pasquale; Nuti, Ranuccio; Gennari, Luigi. - In: THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM. - ISSN 0021-972X. - 105:3(2020), pp. 466-476. [10.1210/clinem/dgz138]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/776595
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