title: Acute effect of zoledronic acid on the risk of cardiac dysrhythmias.
abstract: There have been recent concerns regarding the risk of serious adverse events, such as cardiac dysrhythmia and atrial fibrillation (AF), associated with bisphosphonate use in osteoporosis. This open-label, non-randomized, crossover pilot study evaluated short-term effects of zoledronic acid and placebo on the occurrence of cardiac dysrhythmias and prodysrhythmic profile in postmenopausal women with osteoporosis and low risk of cardiac dysrhythmias. Fifteen postmenopausal women (mean age 70.7 ± 6.9 years) with osteoporosis received placebo infusion on day 1 and zoledronic acid 5 mg on day 7. Standard 12-lead resting EKG measured QT parameters at baseline and up to 24 h after infusion. Continuous 24-h EKG assessed dysrhythmic events and heart rate variability (HRV) for 24 h after infusion. There were no statistically significant differences in resting EKG parameters between placebo and zoledronic acid: QTc (404.28 ± 9.28 and 410.63 ± 18.43 ms), no significant differences in mean serum electrolytes at baseline and after infusion, and no significant association between QT/QTc parameters and serum electrolytes before and after each infusion (QTc: 401.83 ± 17.73 for zoledronic acid and 404.65 ± 16.79 for placebo). There was no significant difference in HRV parameters between placebo and zoledronic acid, and no dysrhythmias were recorded at rest or with 24 h EKG monitoring. Zoledronic acid does not produce dysrhythmia or prodysrhythmic effects in the short term. Among possible mechanisms proposed for cardiac dysrhythmias with zoledronic acid, no serum electrolyte or autonomous nervous system balance perturbations have been reported.
authors.affiliation: Department of Internal Medicine and Medical Disciplines, "Sapienza" University of Rome, Viale del Policlinico 155, 00161, Rome, Italy, cristianac@alice.it.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Cipriani
authors.forename: Claudia
authors.initials: C
authors.lastname: Castro
authors.forename: Mario
authors.initials: M
authors.lastname: Curione
authors.forename: Sara
authors.initials: S
authors.lastname: Piemonte
authors.forename: Federica
authors.initials: F
authors.lastname: Biamonte
authors.forename: Claudio
authors.initials: C
authors.lastname: Savoriti
authors.forename: Jessica
authors.initials: J
authors.lastname: Pepe
authors.forename: Federica
authors.initials: F
authors.lastname: De Lucia
authors.forename: Carolina
authors.initials: C
authors.lastname: Clementelli
authors.forename: Luciano
authors.initials: L
authors.lastname: Nieddu
authors.forename: Salvatore
authors.initials: S
authors.lastname: Minisola
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001145:Arrhythmias, Cardiac / Q000209:etiology*; D004164:Diphosphonates / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects* / Q000627:therapeutic use*; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D010865:Pilot Projects; D012306:Risk; D000077211:Zoledronic Acid
chemical_list: D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid