Glucocorticoid-induced osteoporosis (GIO) is a type of osteoporosis that is caused by the intake of glucocorticoid medicines. Denosumab and risedronate are the two routinely used treatments for GIO. This study aims to compare the safety and efficacy of denosumab and risedronate for the treatment of GIO.
This double-blind, active-controlled, double-dummy, 24-month, non-inferiority study included a total of 795 patients aged 18 years or older who were receiving glucocorticoids for at least three months (glucocorticoid continuing, n=505) or less than three months (glucocorticoid initiating, n=290). The participants were randomly assigned in a 1:1 ratio to receive either 60 mg subcutaneous denosumab (n=398) or 5 mg oral risedronate (n=397) daily for six months. The primary outcome of the study was the non-inferiority of denosumab to risedronate.
The findings suggested that denosumab was not only non-inferior but superior to risedronate at 12 months in terms of bone mineral density at the lumbar spine in both glucocorticoid-continuing (4·4%) and glucocorticoid-initiating (3·8%) participants. The occurrence of adverse events was similar in both groups. The most common adverse events were back pain and arthralgia.
The research concluded that denosumab was superior to risedronate and can be used as a potential treatment option for patients with glucocorticoid-induced osteoporosis.