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Title: Once-yearly zoledronic acid and days of disability, bed rest and back pain: Randomised controlled HORIZON pivotal fracture trial
Authors: Cauley, Jane A ×
Black, Dennis
Boonen, Steven
Cummings, Steven R
Mesenbrink, Peter
Palermo, Lisa
Man, Zulema
Hadji, Peyman
Reid, Ian R
on behalf of the HORIZON Pivotal Fracture Group #
Issue Date: May-2011
Publisher: Blackwell Science, Inc.
Series Title: Journal of Bone and Mineral Research vol:26 issue:5 pages:984-992
Abstract: OBJECTIVE: To determine the effect of once yearly zoledronic acid on the number of days of back pain, and the number of days of disability (limited activity and bed rest) due to back pain or fracture in postmenopausal women with osteoporosis. DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial. SETTING: 240 clinical centres in 27 countries. PARTICIPANTS: 7736 postmenopausal women with osteoporosis. INTERVENTION: Patients were randomised to receive either a single, 15 minute intravenous infusion of zoledronic acid (5 mg) or placebo at baseline, 12 months and 24 months. MAIN OUTCOME MEASURES: Self-reported number of days with back pain, and number of days of limited activity and bed rest due to back pain or a fracture; assessed every three months over a three year period. RESULTS: Although the incidence of back pain was high in both randomised groups, women randomised to zoledronic acid experienced, on average, 18 fewer days of back pain compared with placebo over the course of the trial (p=0.0092). The back pain among women randomised to zoledronic acid versus placebo resulted in 11 fewer days of limited activity (p=0.0017). In Cox proportional hazards models, women randomised to zoledronic acid were about 6% less likely to experience seven or more days of back pain, (RR=0.94, 95% CI 0.90 to 0.99) or limited activity due to back pain (RR=0.94, 95% CI 0.87 to 1.00). Women randomised to zoledronic acid were significantly less likely to experience seven or more bed rest days due to a fracture (RR=0.58, 95% CI 0.47 to 0.72) and seven or more limited activity days due to a fracture (RR=0.67, 95% CI 0.58 to 0.78). Reductions of back pain with zoledronic acid were independent of incident fracture. CONCLUSIONS: In women with postmenopausal osteoporosis, a once yearly infusion with zoledronic acid over a three year period significantly reduced the number of days that patients reported back pain, limited activity due to back pain and limited activity and bed rest due to a fracture. © 2010 American Society for Bone and Mineral Research.
URI: 
ISSN: 0884-0431
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Gerontology and Geriatrics
× corresponding author
# (joint) last author

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