A once-yearly treatment of Reclast(R) (zoledronic acid) Injection significantly reduced the incidence of all types of osteoporotic bone fractures over three years in women with postmenopausal osteoporosis.
This study, published in The New England Journal of Medicine, marks the first time that an osteoporosis treatment significantly reduced all types of fractures in a single study.
Reclast is a bisphosphonate, a class of drugs used to treat osteoporosis, the most common metabolic bone disease affecting more than 10 million people in the US(1). An estimated one out of every two women over age 50 will suffer a broken bone in her lifetime (1).
Unlike other bisphosphonate treatments, where women take daily, weekly or monthly doses for postmenopausal osteoporosis, Reclast is given as a once- yearly 15-minute infusion. Reclast is currently under review by the US Food and Drug Administration (FDA) for the treatment of postmenopausal osteoporosis.
“Unfortunately, many patients who are prescribed oral therapies stop treatment or take less than the full dose throughout a full year, which leads to reduced fracture protection,” said Dennis Black, Ph.D., the study’s lead author and professor of epidemiology and biostatistics at the University of California, San Francisco. “A once-yearly infusion is an exciting potential treatment option because it offers fracture protection for a full year with one dose.”
Results from the study show that Reclast reduced the frequency of fractures among the areas of the body that are typically affected by osteoporosis, including the hip, spine, and wrist. Specifically, a 70 percent reduction was achieved in spine fractures. In the same study, the risk of hip fractures, which are associated with significant mortality (2), was reduced by 41 percent. Additionally, the reduction in spine fractures was sustained over three years (60 percent in year one, 71 percent in year two, and 70 percent in year three).
“We believe Reclast is an innovative treatment approach for the millions of women with osteoporosis and provides impressive fracture reduction, the primary goal of osteoporosis treatment,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG.