Evaluation of the tolerability of zoledronic acid preparations for parenteral administration

Abstract

Introduction. From the perspective of evidence-based medicine, bisphosphonates (BP) represented by several drugs with various routes of administration and dosing regimens have been recognized as the gold standard for the treatment of osteoporosis (OP). Generic BPs are widely used for the treatment of OP due to the availability and optimal balance of cost and effectiveness.The aim is to compare the tolerability of the generic zoledronic acid 5 mg (Osteostatics) and the original zoledronic acid 5 mg (Aclasta).Materials and methods. A total of 54 women aged 56–65 years with postmenopausal OP were enrolled in the study and divided into two groups: 28 patients (Group 1) received intravenous infusions of Osteostatics 5 mg, 26 (Group 2) received Aclasta. Patients in both groups received concomitant therapy with calcium carbonate (1000 mg once a day) and vitamin D (2000 IU once a day). Adverse event data were collected within a week.Results. Among side effects, it was fever that occurred most often: 57.1% in patients receiving Osteostatics (Group 1), and 61.5% in patients receiving Aclasta (Group 2). Headache occurred in 53.5% and 50% of cases, respectively. Side effects such as arthralgia and flu-like syndrome were less common and accounted for 17.8% and 15.4% of cases. Nausea only occurred in 14.2% and 11.5%, myalgia in 42.8% and 38.4%, respectively. In most cases the side effects did not last for more than 48 hours. The frequency and severity of side effects were comparable in patients with comorbidities in both groups.Conclusion. The tolerability of the generic zoledronic acid Osteostatix at a dose of 5 mg is comparable to the original drug Aklasta.

Keywords

• osteoporosis
• bisphosphonates
• zoledronic acid
• side effect
• generic agent