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The FDA, which had previously approved intravenous (IV) administration of 5 mg of zoledronic acid (Reclast – Novartis) once a year for treatment of postmenopausal osteoporosis (Med Lett Drugs Ther 2007; 49:89), has now approved the same dose for use once every 2 years to prevent osteoporosis in postmenopausal women with osteopenia.
Clinical Studies – In an unpublished study summarized in the package insert, 224 women with osteopenia ≤5 years after menopause were given an IV infusion of zoledronic acid 5 mg or placebo; 2 years later, total hip bone mineral density (BMD) had increased by 2.6% with the drug and decreased by 2.1% with placebo. Among 357 osteopenic women >5 years after menopause, hip BMD 2 years after one IV dose of zoledronic acid increased by 2.1% and decreased by 1.0% with placebo. Both of these differences from placebo were... more