title: Safety of Denosumab Versus Zoledronic Acid in Patients with Bone Metastases: A Meta-Analysis of Randomized Controlled Trials.
abstract: BACKGROUND
  Bone metastases lead to local bone destruction and skeletal complications. Bisphosphonates, particlulaly zoledronic acid (ZA), play a central role in the treatment of bone metastases. Some studies have shown that denosumab may delay and prevent SREs in metastatic bone disease more effectively than ZA; therefore, we systematically reviewed and assessed the safety of denosumab and ZA.
  
  
  METHODS
  The PubMed, EMBASE, Cochrane Library, Web of Science with Conference Proceedings, Elsevier, and China National Knowledge Infrastructure (CNKI) databases were searched up to October 2015. 2 independent reviewers extracted data from each eligible study using a standard protocol, and both fixed-effects and random-effects models were used to analyze and evaluate the data extracted from eligible articles.
  
  
  RESULTS
  6 randomized controlled trials enrolling 13,733 patients were included. Occurrences of adverse events were generally similar between the denosumab and ZA groups except anemia and anorexia in patients with bone metastases and back pain and bone pain. However, occurrences of serious adverse events such as hypocalcaemia , renal adverse events , and new primary malignancy were significantly different between the denosumab and ZA groups. Only the occurrence of osteonecrosis of the jaw showed no significant difference between the denosumab and ZA groups in patients with bone metastases.
  
  
  CONCLUSIONS
  Denosumab was safer in delaying or preventing skeletal-related events in patients with bone metastases and prevented pain progression compared to ZA in this meta-analysis.
authors.affiliation: Department of Medical Oncology, General Hospital of The Yangtze River Shipping, Wuhan, China.
authors.forename: Fengxia
authors.initials: F
authors.lastname: Chen
authors.forename: Feifei
authors.initials: F
authors.lastname: Pu
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage; D050071:Bone Density Conservation Agents / Q000008:administration & dosage; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000556:secondary*; D000072716:Cancer Pain / Q000453:epidemiology* / Q000517:prevention & control; D015984:Causality; D015897:Comorbidity; D000069448:Denosumab / Q000008:administration & dosage*; D004164:Diphosphonates / Q000008:administration & dosage*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000517:prevention & control; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D061214:Patient Safety; D015995:Prevalence; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012307:Risk Factors; D016896:Treatment Outcome; D000077211:Zoledronic Acid
chemical_list: D000970:Antineoplastic Agents; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000069448:Denosumab; D000077211:Zoledronic Acid