Reference : Denosumab or zoledronic acid in postmenopausal women with osteoporosis previously tre...
Scientific journals : Article
Human health sciences : General & internal medicine
http://hdl.handle.net/2268/216651
Denosumab or zoledronic acid in postmenopausal women with osteoporosis previously treated with oral bisphosphonates
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Miller, P. D. [Colorado Center for Bone Research, 3190 South Wadsworth Boulevard, Lakewood, CO, United States]
Pannacciulli, N. [Amgen Inc, Thousand Oaks, CA, United States]
Brown, J. P. [Laval University, Centre Hospitalier Universitaire de Québec Research Centre, Québec City, QC, Canada]
Czerwinski, E. [Krakow Medical Center, Krakow, Poland]
Nedergaard, B. S. [Center for Clinical and Basic Research, Aalborg, Aalborg, Denmark]
Bolognese, M. A. [Bethesda Health Research Center, Bethesda, MD, United States]
Malouf, J. [Hospital de la Santa Creu i Sant Pau, Barcelona, Spain]
Bone, H. G. [Michigan Bone and Mineral Clinic, Detroit, MI, United States]
Reginster, Jean-Yves mailto [Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé >]
Singer, A. [Georgetown University Medical Center, Washington, DC, United States]
Wang, C. [Amgen Inc, Thousand Oaks, CA, United States]
Wagman, R. B. [Amgen Inc, Thousand Oaks, CA, United States]
Cummings, S. R. [San Francisco Coordinating Center, California Pacific Medical Center Research Institute, San Francisco, CA, United States]
2016
Journal of Clinical Endocrinology and Metabolism
Endocrine Society
101
8
3163-3170
Yes (verified by ORBi)
International
0021-972X
1945-7197
[en] Article ; Osteoporosis, Postmenopausal ; Administration, Oral ; Aged ; Bone Density ; Bone Density Conservation Agents ; Denosumab ; Diphosphonates ; Double-Blind Method ; Drug Substitution ; Female ; Humans ; Imidazoles ; Middle Aged ; Osteoporosis, Postmenopausal
[en] Context: Denosumab and zoledronic acid (ZOL) are parenteral treatments for patients with osteoporosis. Objective: 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. Design and Setting: This was an international, multicenter, randomized, double-blind trial. Participants:Atotal of 643 postmenopausalwomenwith osteoporosis previously treated with oral bisphosphonates participated in the study. Interventions: Subjects were randomized 1:1 to scdenosumab60mgevery 6 months plus iv placebo once or ZOL 5 mg iv once plus sc placebo every 6 months for 12 months. Main Outcome Measures: Changes in BMD and bone turnover markers were measured. Results: 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). Conclusions: In postmenopausal women with osteoporosis previously treated with oral bisphosphonates, denosumab was associated with greaterBMDincreases at all measured skeletal sites and greater inhibition of bone remodeling compared with ZOL.
http://hdl.handle.net/2268/216651
10.1210/jc.2016-1801

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