Терапевтический архив (Oct 2014)

Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis

  • O B Ershova,
  • O M Lesniak,
  • K Iu Belova,
  • A V Nazarova,
  • A V Manovitskaia,
  • T M Musaeva,
  • R M Mustaev,
  • R Z Nurlygaianov,
  • L Ia Rozhinskaia,
  • I A Skripnikova,
  • N V Toroptsova

Journal volume & issue
Vol. 86, no. 10
pp. 60 – 64

Abstract

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AIM. To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor κВ ligand (RANKL), within an open-label observational study. MATERIALS AND METHODS. Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. RESULTS. Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p

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