WASHINGTON — A yearly dose of zoledronic acid significantly reduced the number of days of disability because of back pain in older women with osteoporotic fractures, based on data from the HORIZON Pivotal Fracture study.
“Osteoporotic fractures can result in back pain, significant disability, reduced quality of life, and death,” Jane A. Cauley, Dr.PH, of the University of Pittsburgh, wrote in a poster at the annual meeting of the American Geriatrics Society.
In the HORIZON Pivotal Fracture Study, a randomized, controlled trial of more than 7,000 postmenopausal women aged 65-79 years, a yearly dose of 5 mg zoledronic acid significantly reduced all types of clinical fractures, compared with placebo. The drug was administered in a 15-minute intravenous infusion.
In the current study, funded by Novartis Pharma AG in Basel, Switzerland, the researchers compared the effect of the yearly dose of zoledronic acid on the number of days of disability, bed rest, and back pain. The intent-to-treat population included 3,875 women who received zoledronic acid and 3,861 who received a placebo. The researchers collected information on days of limited activity and bed rest due to an osteoporotic fracture or back pain every 3 months over a 3-year period.
Older age and a prevalent vertebral fracture were significantly associated with more days of bed rest, back pain, and fracture-related disability.
Overall, women who took zoledronic acid averaged significantly fewer bed rest days because of fracture, versus the placebo group (1.6 days vs. 2.2 days, respectively) and significantly fewer limited-activity days because of fracture, compared with the placebo group (5.9 days vs. 9.9 days). Similarly, women who took zoledronic acid averaged significantly fewer bed rest days because of back pain, compared with those in the placebo group (8.2 days vs. 9.2 days, respectively) and significantly fewer limited-activity days because of back pain, compared with the placebo group (60.5 days vs. 71.9 days).
After controlling for incident clinical fracture, the drug remained significantly tied to fewer days of limited activity.
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