title: [Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis].
abstract: OBJECTIVE
  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 xB ligand (RANKL), within an open-label observational study.
  
  
  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<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases.
  
  
  CONCLUSIONS
  The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.
authors.forename: O B
authors.initials: OB
authors.lastname: Ershova
authors.forename: O M
authors.initials: OM
authors.lastname: Lesniak
authors.forename: K Iu
authors.initials: KIu
authors.lastname: Belova
authors.forename: A V
authors.initials: AV
authors.lastname: Nazarova
authors.forename: A V
authors.initials: AV
authors.lastname: Manovitskaia
authors.forename: T M
authors.initials: TM
authors.lastname: Musaeva
authors.forename: R M
authors.initials: RM
authors.lastname: Musraev
authors.forename: R Z
authors.initials: RZ
authors.lastname: Nurlygaianov
authors.forename: L Ia
authors.initials: LIa
authors.lastname: Rozhinskaia
authors.forename: I A
authors.initials: IA
authors.lastname: Skripnikova
authors.forename: N V
authors.initials: NV
authors.lastname: Toroptsova
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D015415:Biomarkers / Q000378:metabolism; D000069448:Denosumab; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D053245:RANK Ligand / Q000037:antagonists & inhibitors*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D015415:Biomarkers; D053245:RANK Ligand; D000069448:Denosumab