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

Abstract

The aim of this study was to perform a head-to-head comparison of efficacy and safety profile between 60 mg denosumab (Den) subcutaneously (SC) per 6 months (Q6M) and 70 mg alendronate (Aln) orally per week (QW) for postmenopausal women with low bone mineral density. We 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', we identified eligible studies, evaluated the methodological quality and abstracted relevant data. Four heterogeneous randomised controlled trials (RCTs) involving 1942 women were identified. 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.Our review suggested within 1 year 60 mg Den SC Q6M treatment was more effective in increasing bone mass but could not reduce the fracture risk to a greater extent than 70 mg Aln QW therapy. Also the Den SC Q6M therapy did not increase the risks of neoplasms and infections compared with Aln QW.

The Bisphosphonates versus Denosumab Efficiency in Postmenopausal Osteoporosis Treatment

“…The data we obtained are consistent with the data obtained by other meta-analyses [28,29]. We can therefore affirm that Denosumab is more efficient than bisphosphonates in increasing the bone mineral density values after 12 months of treatment.…”

Treating osteoporosis by targeting parathyroid hormone to bone

“…Denosumab is a monoclonal antibody to the Receptor Activator of Nuclear factor Kappa B (RANK) ligand, which acts by inhibiting osteoclast formation. While it serves as a potent antiresorptive agent that is more effective than alendronate at increasing BMD (~4%/year), the additional gains (~1%) fall below the threshold of detection in annual DXA exams (2–3% according to the International Society for Clinical Densitometry standards) and are not accompanied by measurably decreased fracture risk [9]. Odanacatib, a new antiresorptive agent that acts by inhibiting cathepsin K, achieved lower (3.5%) increases in BMD in clinical trials than those typically reported for denosumab [10].…”

Denosumab, a new pharmacotherapy option for postmenopausal osteoporosis

“…No systematic review has yet compared adherence between denosumab and other treatments; the only published data on this issue appear to be from the clinical trials discussed above, suggesting significantly extended time to non-adherence in patients receiving denosumab, relative to those on alendronate 56,57 . A meta-analysis by Lin et al showed that clinical fracture risk and safety concerns did not differ significantly between denosumab and alendronate, although denosumab was significantly more effective than this bisphosphonate at restoring bone mass over 1 year of treatment 61 .…”