Comparison of clinical efficacy and safety between denosumab and alendronate in postmenopausal women with osteoporosis: a meta-analysis

International Journal of Clinical Practice, 04/05/2012

Lin T et al. – This review suggested within 1 year 60mg Den subcutaneously (SC) Q6M treatment was more effective in increasing bone mass but could not reduce the fracture risk to a greater extent than 70mg Aln QW therapy. Also the Den SC Q6M therapy did not increase the risks of neoplasms and infections compared with Aln QW.

Methods

  • The authors searched electronic databases comparing efficacy and safety of Den SC Q6M and Aln QW in postmenopausal women.
  • The primary outcomes of efficacy evaluation in included trials were incidence of clinical fracture in both groups and bone mineral density (BMD) at different skeletal sites.
  • And adverse events (AEs), including incidence of neoplasms and infections, were considered as secondary outcomes.
  • Following the instructions of `Cochrane Handbook for systematic Reviews of Interventions 5.0.2', they identified eligible studies, evaluated the methodological quality and ed relevant data.
  • Four heterogeneous randomised controlled trials (RCTs) involving 1942 women were identified.

Results

  • The results of review showed low evidence quality that supported the hypothesis the denosumab vs. alendronate could reduce risk of fracture [OR (95% CI) 1.42 (0.84 to 2.40), 11 more women per 1000 (from 4 fewer to 36 more), p = 0.19] but the moderate to high quality evidence suggesting treatment with 60 mg Den SC Q6M was more effective for postmenopausal women in increasing BMD [at distal radius (DR), total hip (TH), lumbar spine (LS), and femoral neck (FN)].
  • Hazards of neoplasms [OR (95% CI) 1.10 (0.65 to 1.86), 3 more per 1000 (from 10 fewer to 24 more), p = 0.62] or infections [OR (95% CI) 0.95 (0.79 to 1.15), 12 fewer per 1000 (from 53 fewer to 33 more,), p = 0.62] were appeared to be similar.

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