Denosumab increases bone density in postmenopausal women suffering osteoporosis -
Postmenopausal women with osteoporosis who are long-term denosumab increased bone density, sustained low fracture rate and a favorable benefit / risk profile, a new multinational study found. The findings were presented Sunday, June 22, at ICE / ENDO 2014, the joint meeting of the International Society of Endocrinology and the Endocrine Society in Chicago.
"This study provides reassurance to physicians and their long-long-term treatment patients with denosumab for at least 8 years led to a significant increase in bone density and is safe for women selected appropriately with postmenopausal osteoporosis, "said the study's senior author E. Michael Lewiecki, MD, assistant professor of clinical medicine at the University of New Mexico School of medicine in Albuquerque. "It is important to note that the overall risk of side effects did not increase over time."
Osteoporosis is a long-term illness that occurs when creating a new bone does not take the deletion of old OS. the disease affects mainly postmenopausal women, causing their bones become fragile and brittle, sometimes so a fall or even coughing can cause a fracture. the treatments that reduce the risk of fractures by increasing bone density have significant effects in the long term.
This study showed that long term treatment with denosumab was safe and resulted in continued increases in bone density during the 8 years of treatment with still low fracture rate.
to evaluate the long term efficacy and safety of denosumab to 10 years, Dr. Lewiecki and colleagues conducted the multinational FREEDOM ongoing clinical trial . In this study, the data, the researchers present for up to 8 years of denosumab treatment continues.
Of the nearly 8,000 women originally included in the FREEDOM study, denosumab reduced the risk of vertebral fractures by 68%, reduced their risk of hip fractures by 40%, and reduces risk of vertebral fractures by 20% compared to placebo. Women taking the drug had no increase in their risk for cancer, infection, cardiovascular disease, delayed healing fracture or hypocalcemia.
All the 3,000 women in the long-term extension of the trial took denosumab for up to 8 years, and overall, they showed a continuous increase in bone mineral density average, with a cumulative gain of 8 years 18.4% at the lumbar spine and 8.3% at the total hip, with some fractures and a good safety profile.
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