First Large Randomized Study of Denosumab Reported

The first large randomized study of denosumab is done and the results over 12 months of a 24-month international study, indicate that denosumab increased bone density in the lower spine at a superior rate to risedronate.

The research, “Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study,” appears in the April 6, 2018 edition of The Lancet Diabetes & Endocrinology. 

The study was headed by Kenneth Saag, M.D., the Jane Knight Lowe Professor of Medicine at the University of Alabama at Birmingham. Dr. Saag told OTW, “Steroid induced osteoporosis is the second commonest form of the disease and many patients at risk go unidentified and untreated.”

The authors wrote, “To our knowledge, ours is the first large, randomized controlled trial of denosumab in patients with glucocorticoid-induced osteoporosis who were either prevalent glucocorticoid users or newly initiating glucocorticoid therapy. Denosumab could be a useful addition to the treatment armamentarium for glucocorticoid-induced osteoporosis.”

A total of 795 patients at 79 health care centers in Europe, Latin America, Asia and North America were enrolled. Of these, 505 were glucocorticoid-continuing patients who had received glucocorticoids for at least three months, and 290 were glucocorticoid-initiating patients who had received glucocorticoids for less than three months.

According to the authors, they also found that denosumab was superior to risedronate for bone density measured in the total hip and at the neck of the femur. The researchers emphasize that the study compared denosumab with risedronate, so the relative performance of denosumab compared with osteoporosis treatments besides risedronate has not yet been established.