Generic zoledronic acid for osteoporosis: focus on tolerability and safety

Abstract

Objective: assessment of safety and tolerability of a new generic drug of zoledronic acid (Osteostatics) in patients.

Patients and methods. Clinical observation included 30 postmenopausal women aged 45 years and older (mean age 64±8 years). To determine the safety of the drug of zoledronic acid, all patients underwent biochemical blood test; to assess the tolerability, adverse effects (AE) associated with the administration of the drug were recorded. Fractures that may have occurred during follow-up were also required to be recorded as AE.

Results and discussion. AE was reported by 15 (50.0%) patients. In 13 (43.3%) of them flu-like syndrome (FLS) was noted, including 12 with an increase in body temperature on average to 38.4 [38.0; 38.6] ° C, in 1 (7.7%) – with abdominal pain and nausea, 5 (38.5%) women noted myalgia and/or arthralgia, and 2 (15.4%) – redness and pain in the eyes. In patients who had not previously received bisphosphonate (BP) therapy, AEs were recorded in 62.5% of cases, and in those who had already received such treatment in 15.4%. In most cases, AEs occurred in the first 48 hours, and their duration averaged 2 days.
Conclusion. The incidence of AE was 50.0%, which did not exceed that when using the original zoledronic acid in real clinical practice. The majority of AEs occurred in “naive” patients, developed in the first 2 days after drug administration, and resolved on average within the next 2 days.