Analysis of adverse reactions and related factor of zoledronic acid injection in postmenopausal osteoporosis patients

Abstract

Objective To analyze the adverse reactions and the correlative factor of zoledronic acid injection in postmenopausal osteoporosis patients. Methods The clinical data of postmenopausal osteoporosis patients who were hospitalized in endocrinology department of Xuanwu Hospital during October 2012 to May 2015 were collected. The patients' age, with or without history of bone fracture, with or without receiving bone resorption inhibitors before treatment, the occurrence of adverse reactions including fever, influenza-like symptoms, headache, myalgia, arthralgia on day 3 and 14 after receiving zoledronic acid injection, and the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (Scr) and urea nitrogen (BUN) before and 3 days after receiving zoledronic acid injection were recorded. The related factor of the above-mentioned adverse reactions was analyzed by multifactor logistic regression method. Results A total of 105 medical records of postmenopausal osteoporosis patients were enrolled into the study. The patients'ages ranged from 49-83 years, and the average age was (69±9) years. There were 17 cases with history of bone fracture, and 79 cases who received bone resorption inhibitors before treatment. All the patients received IV infusion of zoledronic acid 5 mg/100 ml. On day 3 after receiving zoledronic acid injection, the overall incidence of adverse reactions and the incidences of fever, influenza-like symptoms, headache, myalgia, and arthralgia were 45.7% (48/105) and 39.0% (41/105), 37.1% (39/105), 26.7% (28/105), 32.4% (34/105), 32.4% (34/105), respectively. On day 14 after receiving zoledronic acid injection, the overall incidence of adverse reactions and the incidences of fever, influenza-like symptoms, headache, myalgia, and arthralgia were 2.9%(3/105), 0, 0, 1.0%(1/105), 1.9% (2/105), 1.0% (1/105), respectively. The overall incidence on day 14 after receiving zoledronic acid injection was obviously lower than that on day 3(P 0.05). The result of multivariate logistic regression analysis showed that the age was negatively correlated with fever, influenza-like symptoms, and myalgia, and irrelevance to headache and arthralgia. Taking bone resorption inhibitors before receiving zoledronic acid injection was negatively correlated with the five kinds of adverse reactions mentioned above. The overall incidence and the above-mentioned five kinds of adverse reactions in patients age ≥ 60 years were lower than those in the patients aged<60 years (P<0.01, P<0.05, respectively). Conclusions The common adverse reactions of zoledronic acid injection in postmenopausal osteoporosis patients are fever, influenza-like symptoms, headache, myalgia, and arthralgia. The age and the history of receiving bone resorption inhibitors are negatively related to the above-mentioned adverse reactions. Key words: Zoledronic acid; Osteoporosis, postmenopausal; Drug toxicity; Risk factors