title: [Effectiveness and tolerability of zoledronic acid in the treatment of metastatic prostate cancer].
abstract: OBJECTIVE
  To assess the effectiveness and tolerability of zoledronic acid in prostate cancer patients with bone metastases at the hormone-sensitive (HS) and hormone-independent (HI) stages.
  
  
  METHODS
  A nationwide, observational, prospective, open and multi-centre trial was devised, with a total of 218 male patients diagnosed with prostate cancer at the HS stage (36%) or HI stage (64%) who were administered zoledronic acid (4 mg/IV/month for 6 months) in addition to their specific oncological treatment. Effectiveness was assessed by the following means: 1) Assessment of the improvement in pain and mobility; 2) Incidence and time to onset of skeletal-related events (SREs) and 3) Analysis of bone markers. Tolerability was assessed by means of registering the number and type of adverse effects. A satisfaction survey was carried out amongst the patients after the end of the trial.
  
  
  RESULTS
  Out of the 218 patients, 170 (78%) were evaluable for effectiveness. A decrease in pain ratings at rest and during movement was observed in all patients, whether in the HS or HI groups (p < 0.0001). Improved mobility was observed likewise (p = 0.005), as was quality of life. The global incidence of skeletal events was 11.2%, with a time to onset of SREs of 10.7 months. There were no significant differences observed between HS vs. HI patients. Osteolysis markers (N-telopeptide) decreased significantly with the treatment across both the HS and HI groups. For safety reasons. 212 patients were evaluable (97.2%). The incidence of adverse drug reactions was 16% (34/212) and was found to be significantly higher in HS patients (22.4%) compared with HI patients (11.9%). Overall, the tolerability of zoledronic acid was good, with no significant morbidity in either group (HS and HI). 66% of the patients reported feeling satisfied or very satisfied.
  
  
  CONCLUSIONS
  Zoledronic acid proved effective in the relief of pain, improving mobility and quality of life as well as reducing or delaying the occurrence of skeletal-related events in prostate cancer patients presenting metastatic bone disease, regardless of the phase, whether HS or HI, they found themselves in. Tolerability and patient satisfaction were rates as good.
authors.affiliation: Servicio de Urología H. Universitario Virgen de las Nieves, Granada. cozarjm@yahoo.es
authors.forename: J M
authors.initials: JM
authors.lastname: Cózar Olmo
authors.forename: J
authors.initials: J
authors.lastname: Carballido Rodriguez
authors.forename: P
authors.initials: P
authors.lastname: Luque Galvez
authors.forename: A G
authors.initials: AG
authors.lastname: Tabernero Gómez
authors.forename: A
authors.initials: A
authors.lastname: Barreiro Mouro
authors.forename: E
authors.initials: E
authors.lastname: Sánchez Sánchez
authors.forename: C
authors.initials: C
authors.lastname: González Enguita
authors.forename: J
authors.initials: J
authors.lastname: Alcover García
authors.forename: E
authors.initials: E
authors.lastname: Garcia-Galisteo
authors.forename: J M
authors.initials: JM
authors.lastname: Abascal García
authors.forename: M
authors.initials: M
authors.lastname: Sanchez Chapado
authors.forename: F
authors.initials: F
authors.lastname: GómezVeiga
authors.forename: R J
authors.initials: RJ
authors.lastname: Minguez Martínez
authors.forename: A
authors.initials: A
authors.lastname: Rodriguez Antolin
authors.forename: R A
authors.initials: RA
authors.lastname: Medina López
authors.forename: M
authors.initials: M
authors.lastname: Rico Morales
authors.forename: F J
authors.initials: FJ
authors.lastname: Regadera Sejas
authors.forename: S
authors.initials: S
authors.lastname: Búcar Terrades
authors.forename: D
authors.initials: D
authors.lastname: Jamardo Gonzalez
authors.forename: R
authors.initials: R
authors.lastname: Gálvez
mesh_terms: D000368:Aged; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000150:complications* / Q000556:secondary*; D004164:Diphosphonates / Q000627:therapeutic use*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology*; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid