Article; Osteoporosis, Postmenopausal; Administration, Oral; Aged; Bone Density; Bone Density Conservation Agents; Denosumab; Diphosphonates; Double-Blind Method; Drug Substitution; Female; Humans; Imidazoles; Middle Aged
Abstract :
[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.
Disciplines :
General & internal medicine
Author, co-author :
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 ; 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
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