Denosumab or zoledronic acid in postmenopausal women with osteoporosis previously treated with oral bisphosphonates
Miller, P.D. (Colorado Center for Bone Research)
Pannacciulli, N. (Amgen Inc)
Brown, J.P. (Laval University)
Czerwinski, E. (Krakow Medical Center)
Nedergaard, B.S. (Center for Clinical and Basic Research)
Bolognese, M.A. (Bethesda Health Research Center)
Malouf Sierra, Jorge 1971- (Institut d'Investigació Biomèdica Sant Pau)
Bone, H.G. (Michigan Bone and Mineral Clinic)
Reginster, J. Y. (University of Liège)
Singer, A. (Georgetown University Medical Center)
Wang, C. (Amgen Inc)
Wagman, R.B. (Amgen Inc)
Cummings, S.R. (California Pacific Medical Center Research Institute)
Universitat Autònoma de Barcelona

Data:	2016
Resum:	Denosumab and zoledronic acid (ZOL) are parenteral treatments for patients with osteoporosis. 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. This was an international, multicenter, randomized, double-blind trial. Atotal of 643 postmenopausalwomenwith osteoporosis previously treated with oral bisphosphonates participated in the study. 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. Changes in BMD and bone turnover markers were measured. 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). 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	The journal of clinical endocrinology & metabolism, Vol. 101 Núm. 8 (august 2016) , p. 3163-3170, ISSN 1945-7197

DOI: 10.1210/jc.2016-1801
PMID: 27270237

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