The first comparative study between two molecules that prevent fractures in women in the post-menopausal period carries the signature of Maria Luisa Brandi, a professor of endocrinology at the University of Florence, and a team of international researchers working on osteoporosis. The results were illustrated in an article recently published by The New England Journal of Medicine (DOI: 10.1056 / NEJMoa1708322).
The study was carried out on 4,093 women and lasted about two years. Half of the patients received a romosozumab treatment for 12 months associated with alendronate during the same period. The treatments were followed by 12 months of alendronate therapy.
"What we have done is a registration-type study," explains Maria Luisa Brandi, "which determines whether or not a molecule is effective for the purpose of registration in the international pharmacopoeia."
"More generally, says Brandi, this publication on osteoporosis is an example of how important the role of university researchers in clinical trials is, and how certain skills are crucial to obtaining studies from industries at international level."
Research has shown that after 24 months the first group had reported only 6.2% new vertebral fractures, compared to 11.9% of the second (48% reduction in favor of romosozumab). 9.7% of patients in the first group reported clinical fractures, in the second the percentage rises to 13% (risk reduction of 27%).
The response was for non-vertebral fractures was along the same lines, with a decrease of cases of 19%. As regards to cardiovascular adverse events, and incidence of 2.5% was observed in patients treated with romosuzumab versus 1.9% in the alendronate group.