TY - JOUR
TI - Denosumab compared with risedronate in postmenopausal women suboptimally
adherent to alendronate therapy: Efficacy and safety results from a
randomized open-label study
AU - Roux, C.
AU - Hofbauer, L. C.
AU - Ho, P. R.
AU - Wark, J. D. and
AU - Zillikens, M. C.
AU - Fahrleitner-Pammer, A.
AU - Hawkins, F.
AU - Micaelo,
AU - M.
AU - Minisola, S.
AU - Papaioannou, N.
AU - Stone, M.
AU - Ferreira, I.
AU - and Siddhanti, S.
AU - Wagman, R. B.
AU - Brown, J. P.
JO - Bone
PY - 2014
VL - 58
TODO - null
SP - 48-54
PB - EXCERPTA MEDICA INC-ELSEVIER SCIENCE INC
SN - 8756-3282
TODO - 10.1016/j.bone.2013.10.006
TODO - Denosumab; Postmenopausal osteoporosis; Risedronate; Bone mineral
density; Bone turnover markers
TODO - Denosumab has been shown to reduce new vertebral, nonvertebral, and hip
fractures in postmenopausal women with osteoporosis. In subjects who
were treatment-naive or previously treated with alendronate, denosumab
was associated with greater gains in bone mineral density (BMD) and
decreases in bone turnover markers when compared with
alendronate-treated subjects. This trial was designed to compare the
efficacy and safety of denosumab with risedronate over 12 months in
postmenopausal women who transitioned from daily or weekly alendronate
treatment and were considered to be suboptimally adherent to therapy.
In this randomized, open-label study, postmenopausal women aged >= 55
years received denosumab 60 mg subcutaneously every 6 months or
risedronate 150 mg orally every month for 12 months. Endpoints included
percentage change from baseline in total hip BMD (primary endpoint),
femoral neck, and lumbar spine BMD at month 12, and percentage change
from baseline in sCTX-1 at months 1 and 6. Safety was also assessed.
A total of 870 subjects were randomized (435, risedronate; 435,
denosumab) who had a mean (SD) age of 67.7 (6.9) years, mean (SD) BMD
T-scores of -1.6 (0.9), -1.9 (0.7), and -2.2 (1.2) at the total hip,
femoral neck, and lumbar spine, respectively, and median sCTX-1 of 03
ng/mL at baseline. At month 12, denosumab significantly increased BMD
compared with risedronate at the total hip (2.0% vs 0.5%), femoral
neck (1.4% vs 0%), and lumbar spine (3.4% vs 1.1%; p<0.0001 at all
sites). Denosumab significantly decreased sCTX-1 compared with
risedronate at month 1 (median change from baseline of -78% vs -17%;
p<0.0001) and month 6 (-61% vs -23%; p<0.0001). Overall and serious
adverse events were similar between groups.
In postmenopausal women who were suboptimally adherent to alendronate
therapy, transitioning to denosumab was well tolerated and more
effective than risedronate in increasing BMD and reducing bone turnover.
(C) 2013 The Authors. Published by Elsevier Inc. All rights reserved.
ER -