May 31, 2017
Postmenopausal women with osteoporosis assigned denosumab therapy for up to 10 years saw sustained gains in bone mineral density and reductions in bone turnover with low fracture incidence vs. women assigned to placebo, according to an analysis of the FREEDOM extension trial.
“The year-by-year results show that the safety profile of denosumab remained consistent and favorable over 10 years of treatment,” Henry G. Bone, MD, of the division of metabolism, endocrinology and diabetes at the University of Michigan in Ann Arbor, and colleagues wrote. “In this aging population, the participant incidence of adverse events — such as serious infection, cellulitis, eczema and malignancy — remained low. ... Thus, many of the questions that were initially raised about long-term safety with denosumab’s unique mechanism of action have largely been addressed.”