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Effects of intravenous zoledronic acid plus subcutaneous teriparatide [(1-34)rhPTH] in postmenopausal osteoporosis.

Author(s): Cosman F, Eriksen EF, Recknor C, Miller PD, Guanabens N, Kasperk C, Papanastasiou P, Readie A, Rao H, Gasser JA, Bucci-Rechtweg C, Boonen S

Affiliation(s): Clinical Research Center, Helen Hayes Hospital, West Haverstraw, NY, USA.

Publication date & source: 2010-09-02, J Bone Miner Res., [Epub ahead of print]

Clinical data suggest concomitant therapy with bisphosphonates and PTH may blunt the anabolic effect of PTH; rodent models suggest infrequently administered bisphosphonates might interact differently. To evaluate the effects of combination therapy with an intravenous infusion of zoledronic acid 5 mg and daily subcutaneous (1-34)rhPTH (teriparatide) 20 microg versus either agent alone on BMD and bone turnover markers, we conducted a 1-yr multicenter, multinational, randomized, partial double-blinded, controlled trial. In this multicenter, multinational study, 412 postmenopausal women with osteoporosis (mean age, 65 +/- 9 yr) were randomized to a single infusion of zoledronic acid 5 mg plus daily subcutaneous teriparatide 20 microg (n = 137), zoledronic acid alone (n = 137), or teriparatide alone (n = 138). The primary endpoint was percentage increase in lumbar spine BMD (assessed by DXA) at 52 wk versus baseline. Secondary endpoints included change in BMD at the spine at earlier time points and at the total hip, trochanter, and femoral neck at all time points. At week 52, lumbar spine BMD had increased 7.5%, 7.0%, and 4.4% in the combination, teriparatide, and zoledronic acid groups, respectively (p < 0.001 for combination and teriparatide versus zoledronic acid). In the combination group, spine BMD increased more rapidly than with either agent alone (p < 0.001 versus both teriparatide and zoledronic acid at 13 and 26 wk). Combination therapy increased total hip BMD more than teriparatide alone at all times (all p < 0.01) and more than zoledronic acid at 13 wk (p < 0.05), with final 52-wk increments of 2.3%, 1.1%, and 2.2% in the combination, teriparatide, and zoledronic acid groups, respectively. With combination therapy, bone formation (assessed by serum P1NP) increased from 0-4 wks, declined minimally from 4-8 wks, then rose throughout the trial, with levels above baseline from 6 to 12 months. Bone resorption (assessed by serum beta-CTx) was markedly reduced with combination therapy from 0-8 wks (a reduction of similar magnitude to that seen with zoledronic acid alone), followed by a gradual increase after wk 8, with levels remaining above baseline for the latter half of the year. Levels for both markers were significantly lower with combination therapy versus teriparatide alone (p < 0.002). Limitations of the study included its short duration, lack of end points beyond DXA-based BMD (e.g., QCT and finite element modeling for bone strength), lack of teriparatide placebo, insufficient power for fracture outcomes. We conclude that, while teriparatide increases spine BMD more than zoledronic acid and zoledronic acid increases hip BMD more than teriparatide, combination therapy provides the largest, most rapid increments when both spine and hip sites are considered. (c) 2010 American Society for Bone and Mineral Research.

Page last updated: 2010-10-05

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