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

• Published in: Osteoporoz i osteopatii Vol. 17; no. 3; pp. 22 - 26
• Main Authors: Marchenkova, L A, Dreval, A V, Baharev, I V
• Format: Journal Article
• Language: English
• Published: Endocrinology Research Centre 15.12.2014
• Subjects: бисфосфонаты; дженерик; золедроновая кислота; остеопороз
• ISSN: 2072-2680; 2311-0716
• DOI: 10.14341/osteo2014322-26

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.