Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study

This study is registered with ClinicalTrials.gov (NCT01575873) and is completed.FindingsBetween March 28, 2012, and June 30, 2015, 795 patients, 505 of whom were glucocorticoid continuing and 290 of whom were glucocorticoid initiating, were enrolled and randomly assigned (398 to denosumab, 397 to risedronate). Denosumab was both non-inferior and superior to risedronate at 12 months for effect on bone mineral density at the lumbar spine in both glucocorticoid-continuing (4·4% [95% CI 3·8–5·0] vs 2·3% [1·7–2·9]; p<0·0001) and glucocorticoid-initiating (3·8% [3·1–4·5] vs 0·8% [0·2–1·5]; p<0·0001) subpopulations. Incidence of adverse events, serious adverse events (including infections), and fractures was similar between treatment groups. The most common adverse events were back pain (17 [4%] patients in the risedronate group and 18 [5%] in the denosumab group) and arthralgia (21 [5%] patients in the risedronate group and 17 [4%] in the denosumab group). Serious infection occurred in 15 (4%) patients in the risedronate group and 17 (4%) patients in the denosumab group.InterpretationDenosumab could be a useful treatment option for patients newly initiating or continuing glucocorticoids who are at risk of fractures.FundingAmgen.
Source: The Lancet Diabetes and Endocrinology - Category: Endocrinology Source Type: research