A new study indicates that a once-a-year infusion of zoledronic acid (Zometa) greatly reduces a postmenopausal woman's risk of bone fractures. The findings could help spur FDA approval for this use of the drug.
The study involved 3,889 women with postmenopausal osteoporosis who were randomly assigned to a 15-minute dose of I.V. zoledronate (5 mg I.V.) and 3,876 women who received a placebo. Women received the drug or placebo at baseline, 12 months, and 24 months. Researchers followed the women for 36 months.
Treatment with zoledronate reduced the risk of vertebral fractures by 70% and hip fractures by 41%. The drug also reduced the risk of other fractures, reduced bone turnover, and improved bone mineral density.
Most women tolerated the drug well, but serious atrial fibrillation, while uncommon, affected significantly more women who took zoledronate.
Clinicians applauded the treatment as a promising option for some women who have trouble adhering to current drug therapies for osteoporosis that require daily, weekly, or monthly dosing.
The study was funded by Novartis Pharma, which manufactures Zometa.