title: Safety of denosumab in postmenopausal women with osteoporosis or low bone mineral density: a meta-analysis.
abstract: OBJECTIVE
  The aim of this meta-analysis was to assess the safety of denosumab in postmenopausal women with osteoporosis or low bone mineral density (BMD).
  
  
  METHODS
  Safety of denosumab was compared with placebo or bisphosphonates. A systematic literature search without language restriction was conducted up to January, 2014. The RevMan 5.1 software was used for statistical analysis.
  
  
  RESULTS
  A total of 11 English literatures were eventually identified. The pooled data in the overall analysis revealed that there was no significant difference when compared denosumab with placebo or bisphosphonates in any adverse events (AAE) (RR=0.99, 95% CI=0.98-1.01, p=0.29), serious adverse event (SAE) (RR=1.05, 95% CI=0.98-1.13, p=0.18), neoplasm/cancer (RR=1.14, 95% CI=0.95-1.37, p=0.16) and deaths (RR=0.77, 95% CI=0.57-1.04, p=0.09). However, significant differences were found when compared denosumab with placebo or bisphosphonates in SAE related to infection (RR=1.23, 95% CI=1.00-1.52, p=0.05) and non-vertebral fracture (RR=0.86, 95% CI=0.74-1.00, p=0.05). Subgroup analysis was performed by the type of drugs which was used in the control group. The results of subgroup analysis did not demonstrate the differences between denosumab and bisphosphonates in SAE related to infection (RR=1.13, 95% CI=0.63-2.03) and non-vertebral fracture (RR=1.31, 95% CI=0.87-1.98).
  
  
  CONCLUSIONS
  Compared to placebo, denosumab treatment significantly decreased the risk of non-vertebral fracture but increased the risk of SAE related to infection in the postmenopausal women with osteoporosis or low BMD. However, no difference between the safety of denosumab and bisphosphonates was found.
authors: Department of Orthopedic Surgery, Jinan Military General Hospital of PLA Jinan 250031, Shandong Province, China.
authors: Zhenyu
authors: Z
authors: Zhou
authors: Department of Orthopedic Surgery, Jinan Military General Hospital of PLA Jinan 250031, Shandong Province, China.
authors: Chen
authors: C
authors: Chen
authors: Department of Orthopedic Surgery, Jinan Military General Hospital of PLA Jinan 250031, Shandong Province, China.
authors: Jun
authors: J
authors: Zhang
authors: Department of Orthopaedic, PLA General Hospital 28 Fuxing Road, Beijing, 100000, PR China.
authors: Xinran
authors: X
authors: Ji
authors: Department of Orthopedic Surgery, Jinan Military General Hospital of PLA Jinan 250031, Shandong Province, China.
authors: Lifeng
authors: L
authors: Liu
authors: Department of Orthopedic Surgery, Jinan Military General Hospital of PLA Jinan 250031, Shandong Province, China.
authors: Guichun
authors: G
authors: Zhang
authors: Department of Orthopedic Surgery, Jinan Military General Hospital of PLA Jinan 250031, Shandong Province, China.
authors: Xuecheng
authors: X
authors: Cao
authors: Department of Orthopedic Surgery, Jinan Military General Hospital of PLA Jinan 250031, Shandong Province, China.
authors: Pingshan
authors: P
authors: Wang
mesh_terms: D000367:Age Factors; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D000069448:Denosumab; D005260:Female; D006801:Humans; D016017:Odds Ratio; D015663:Osteoporosis, Postmenopausal / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D058866:Osteoporotic Fractures / Q000175:diagnosis / Q000503:physiopathology / Q000517:prevention & control*; D018570:Risk Assessment; D012307:Risk Factors; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D050071:Bone Density Conservation Agents; D000069448:Denosumab
keywords: Denosumab; meta-analysis; osteoporosis; postmenopausal women