A new study provides reassuring information about the short-term and long-term safety of denosumab, a monoclonal antibody that is used to treat postmenopausal osteoporosis.
Adverse events that had been noted in a pivotal clinical trial in women age 60 to 90 years old treated for 3 years showed no tendency to increase after a further 3 years of treatment, the study showed.
In addition, women who crossed over from 3 years of placebo to 3 years of denosumab experienced no increase in adverse effects compared with women treated for the initial 3 years.
"All of this is consistent with an excellent safety and tolerability profile for denosumab treatment for osteoporosis," said Dr. Nelson Watts, lead author of the study results published in Journal of Bone and Mineral Research. The authors noted that, especially in older women on long-term treatment, many if not all adverse events could be called "life events" -things that would have happened whether or not the person was participating in a clinical trial.
Article: Safety Observations With Three Years of Denosumab Exposure: Comparison Between Subjects Who Received Denosumab During the Randomized FREEDOM Trial and Subjects Who Crossed Over to Denosumab During the FREEDOM Extension, NB Watts, JP Brown, S Papapoulos, EM Lewiecki, DL Kendler, P Dakin, RB Wagman, A Wang, NS Daizadeh, S Smith, HG Bone, Journal of Bone and Mineral Research, doi: 10.1002/jbmr.3119, published online 9 March 2017.