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- Title
Denosumab or Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates.
- Authors
Miller, P D; Pannacciulli, N; Brown, J P; Czerwinski, E; Nedergaard, B S; Bolognese, M A; Malouf, J; Bone, H G; Reginster, J-Y; Singer, A; Wang, C; Wagman, R B; Cummings, S R
- Abstract
<bold>Context: </bold>Denosumab and zoledronic acid (ZOL) are parenteral treatments for patients with osteoporosis.<bold>Objective: </bold>The objective of the study was to compare the effect of transitioning from oral bisphosphonates to denosumab or ZOL on bone mineral density (BMD) and bone turnover.<bold>Design and Setting: </bold>This was an international, multicenter, randomized, double-blind trial.<bold>Participants: </bold>A total of 643 postmenopausal women with osteoporosis previously treated with oral bisphosphonates participated in the study.<bold>Interventions: </bold>Subjects were randomized 1:1 to sc denosumab 60 mg every 6 months plus iv placebo once or ZOL 5 mg iv once plus sc placebo every 6 months for 12 months.<bold>Main Outcome Measures: </bold>Changes in BMD and bone turnover markers were measured.<bold>Results: </bold>BMD change from baseline at month 12 was significantly greater with denosumab compared with ZOL at the lumbar spine (primary end point; 3.2% vs 1.1%; P < .0001), total hip (1.9% vs 0.6%; P < .0001), femoral neck (1.2% vs -0.1%; P < .0001), and one-third radius (0.6% vs 0.0%; P < .05). The median decrease from baseline was greater with denosumab than ZOL for serum C-telopeptide of type 1 collagen at all time points after day 10 and for serum procollagen type 1 N-terminal propeptide at month 1 and at all time points after month 3 (all P < .05). Median percentage changes from baseline in serum intact PTH were significantly greater at months 3 and 9 with denosumab compared with ZOL (all P < .05). Adverse events were similar between groups. Three events consistent with the definition of atypical femoral fracture were observed (two denosumab and one ZOL).<bold>Conclusions: </bold>In postmenopausal women with osteoporosis previously treated with oral bisphosphonates, denosumab was associated with greater BMD increases at all measured skeletal sites and greater inhibition of bone remodeling compared with ZOL.
- Publication
Journal of Clinical Endocrinology & Metabolism, 2016, Vol 101, Issue 8, p3163
- ISSN
0021-972X
- Publication type
journal article
- DOI
10.1210/jc.2016-1801