Treatment of osteoporosis in clinical practice: first experience with the Russian generic drug of zoledronic acid

Abstract

Objective: to evaluate the effect of the generic drug of zoledronic acid on bone mineral density (BMD) and markers of bone metabolism in patients with osteoporosis (OP), as well as possible long-term adverse reactions (AR) 12 months after drug administration.Patients and methods. The study included 30 postmenopausal women with OP (mean age 64±8 years) who signed an informed consent of participance in clinical observation. Patients received a single dose of generic zoledronic acid (5 mg) as a 15-minute infusion. All patients additionally took calcium and vitamin D. The dynamics of BMD and bone metabolism markers, as well as the safety and tolerability of the drug, were evaluated. Fractures that might have occurred during follow-up should have been reported as ARs.Results and discussion. During treatment with generic zoledronic acid, the increase in BMD in the lumbar region was 4.9% (p<0.0001), in the femoral neck –2.7% (p<0.01), and in the femur as a whole – 3.0% (p<0.0001). Positive dynamics (increase in BMD>2%) in the spine was detected in 26 (86.7%) patients, in the proximal femur – in 20 (66.7%) patients. There was a decrease in the intensity of pain in both the thoracic (by 62%; p=0.038) and lumbar (by 29%; p=0.022) spine. Three months after the administration of the drug, a decrease in the level of bone metabolism markers was revealed: CTX – by an average of 29.7%, and P1NP – by an average of 25.5%. ARs were post-dose reactions that occurred within the first 48 hours after drug infusion. Remote ARs, fractures of peripheral bones and vertebrae were not recorded.Conclusion. The use of the generic drug of zoledronic acid has demonstrated its positive effect on BMD and markers of bone metabolism, as well as safety.