Combined osteoporosis therapy boosts BMD
medwireNews: Teriparatide and denosumab are significantly more effective at increasing bone mineral density (BMD) in postmenopausal women when given together than when either agent is given alone, osteoporosis trial findings indicate.
The DATA study included data for 94 women who were randomly assigned to receive teriparatide 20 µg daily (n=31), denosumab 60 mg every 6 months (n=33), or both agents (n=30), the research team reports in The Lancet.
Although all three groups achieved a significant increase in posterior-anterior lumbar spine BMD after 12 months of treatment, combined treatment was associated with a significantly greater increase than teriparatide or denosumab treatment given alone (9.1 vs 6.2 and 5.5%, respectively).
Double treatment was also associated with a significantly greater increase in total hip BMD (4.9 vs 0.7 and 2.5%) and BMD at the femoral neck (4.2 vs 0.8 and 2.1%) than teriparatide or denosumab alone.
Levels of the type I collagen metabolite PINP - a marker of bone turnover - significantly decreased from baseline over 12 months for patients given combined or denosumab only therapy but suppression was lower with combined therapy at 3 and 6 months, and comparable at 12 months.
"Although studies are needed to assess reductions in fracture risk and to explore the effects of different doses and durations of treatment, the results of this trial suggest that this specific combination of drugs could be a useful option in the treatment of patients with osteoporosis at especially high risk of fracture," say Benjamin Leder and co-authors from Massachusetts General Hospital in Boston, USA.
Writing in an accompanying comment, Richard Eastall (Northern General Hospital, Sheffield, UK) and Jennifer Walsh (University of Sheffield, UK) say the results "provide proof of concept" for the additive effect of the recombinant parathyroid hormone and anti-RANKL monoclonal antibody agents.
However, they caution: "Whether the combination remains effective needs to be investigated, however, because at 12 months mean concentrations of the bone formation marker PINP no longer differed between the denosumab-alone and combination-therapy groups."
Eastell and Walsh add that further research is required to quantify the reduction in fracture risk associated with combined treatment, to allow cost-efficacy analysis, and to determine what happens after patients complete the maximum recommended 2-year regimen of teriparatide.
medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2013
By Lynda Williams, Senior medwireNews Reporter