EFFICACY AND TOLERABILITY OF GENERIC ZOLEDRONIC ACID 5 MG (REZOCLASTIN PS) IN THE TREATMENT OF OSTEOPOROSIS: A RETROSPECTIVE ANALYSIS OF CLINICAL EXPERIENCE WITH THE DRUG IN RUSSIA

Abstract

Objectives. To analyze clinical data of the first domestic zoledronic acid generic preparation for the treatment of osteoporosis (Rezoclastin PS., 5 mg). Materials and Methods. The study included data from 123 patients (118 women and 5 men) treated with Rezoclastin PS 5 mg in medical centers of Moscow, St.-Petersburg and Krasnodar for primary (91.8%) or secondary(8.2%) osteoporosis, with mean age 27-78 years (61,4 ± 9,1 years). 56.6% of patients had severe osteoporosis with compressive deformations of vertebrae. Duration of medical therapy ranged from 6 to 24 months. Results. Study of changers in bone resorption marker CTx (n = 10) showed decline by 78% after 3 months of treatment compared to baseline (p = 0.027). BMD at the lumbar segment of the spine L 1-L 4 increased after 12 months by 3.4% (p <0.001, n = 87) and 24 months by 5.7% (p <0.05, n = 11) at the femoral neck - by 1.6% (p <0.0001, n = 64) and by 2.5% (p <0.05, n = 11), respectively, and in the total proximal femur - by 2.6% (p <0.01, n = 64) and by 3.8% (p <0.05, n = 11), respectively. The level of back pain in the study group significantly decreased at 6 months (p <0.000001), and after 18 and 24 months the pain in most patients subsided. After the first administration of the drug in 40% of patients had adverse events, mainly due to flu-like syndrome. After the second infusion at 12 months adverse reactions rate decreased to only 22.9%, after the third infusion at 24 months to 1.8 %. Conclusions. The parameters of efficacy and adverse reactions of the generic zoledronic acid as our data show is comparable to the brand version of the drug.

Keywords

• золедроновая кислота
• дженерик
• остеопороз
• бисфосфонаты