A 60 mg dose of subcutaneous denosumab administered every 6 months for 24 months was superior to once daily oral risedronate for increasing hip and spine bone mineral density (BMD) for patients with glucocorticoid-induced osteoporosis, with a similar overall safety profile, according to a study published in Arthritis & Rheumatology.
This randomized, phase 3, double-blind, double-dummy trial compared the efficacy and safety of subcutaneous denosumab 60 mg administered once every 6 months with once-daily oral risedronate 5 mg. Participants were men and women at least 18 years of age who had been receiving at least 7.5 mg of prednisone or equivalent daily for less than 3 months (glucocorticoid-initiating group) or for 3 months or more (glucocorticoid-continuing group). Participants were randomly assigned to denosumab or risedronate groups for 24 months, with daily vitamin D and calcium.
Of the initial 795 participants, 590 (74.2%) completed the study. In the glucocorticoid-initiating group, 109 participants received denosumab and 117 received risedronate, and in the glucocorticoid-continuing group, 186 received denosumab and 178 received risedronate. At every time point assessed, denosumab was shown to be superior to risedronate for increasing lumbar spine and total hip BMD among glucocorticoid-initiating participants (24-month lumbar spine BMD: 6.2% vs 1.7%; P <.001; and 24-month total hip BMD: 3.1% vs 0.0%; P <.001) and glucocorticoid-continuing participants (24-month lumbar spine BMD: 6.4% vs 3.2%; P <.001; and 24-month total hip BMD: 2.9% vs 0.5%; P <.001). Rates of serious adverse events, adverse events, and fractures were similar between groups.
Study investigators concluded that denosumab was superior to risedronate with a similar safety profile, and that denosumab may offer a new treatment option for glucocorticoid-treated patients with osteoporosis.
Amgen Inc. funded the study and participated in the design. Several authors report associations with pharmaceutical entities. For a full list of author disclosures, please see original article.
Saag KG, Pannacciulli N, Geusens P, et al. Denosumab vs risedronate in glucocorticoid-induced osteoporosis: final results of a 24-month randomized, double-blind, double-dummy trial [published online February 28, 2019]. Arthritis Rheumatol. doi: 10.1002/art.40874