Denosumab vs risedronate in glucocorticoid-induced osteoporosis: final results of a 24-month randomized, double-blind, double-dummy trial.
Arthritis Rheumatol. 2019 Feb 28;: Authors: Saag KG, Pannacciulli N, Geusens P, Adachi JD, Messina OD, Morales-Torres J, Emkey R, Butler PW, Yin X, Lems WF
OBJECTIVE: In glucocorticoid-treated subjects, denosumab 60 mg subcutaneously once every 6 months (Q6M) increased spine and hip bone mineral density (BMD) significantly more than risedronate 5 mg orally once daily (QD) at month 12, as previously reported. This final analysis compared efficacy and characterized safety through month 24. METHODS: This phase 3 study enrolled men and women aged ≥18 years receiving ≥7.5 mg daily prednisone or equivalent for <3 months (glucocorticoid-initiating) or ≥3 months (glucocorticoid-continuing) before screening. All subjects aged <50 years had a history of osteoporotic fracture. Glucocorticoid-continuing subjects aged ≥50 years had T-score ≤-2.0 (or ≤-1.0 with fracture history). Subjects were randomized (1:1) to denosumab 60 mg subcutaneously Q6M or risedronate 5 mg orally QD for 24 months, with daily calcium and vitamin D. RESULTS: Of 795 subjects, 590 (74.2%) completed the study (glucocorticoid-initiating: 109/145 denosumab, 117/145 risedronate; glucocorticoid-continuing: 186/253 denosumab, 178/252 risedronate). Denosumab was superior to risedronate for increases in lumbar spine and total hip BMD at all time points assessed among glucocorticoid-initiating subjects (24-month lumbar spine: 6.2% vs 1.7%, p<0.001; 24-month total hip: 3.1% vs 0.0%, p<0.001) and glucocorticoid-continuing subjects (24-month lumbar spine: 6.4% vs 3.2%, p<0.001; 24-month total hip: 2.9% vs 0.5%, p<0.001). Adverse events, serious adverse events (including infections), and fractures were similar between treatment groups. CONCLUSION: Denosumab was superior to risedronate for increases in spine and hip BMD through month 24 and the safety profile was similar between treatment groups. Denosumab may offer a new osteoporosis treatment option for glucocorticoid-treated patients. This article is protected by copyright. All rights reserved. PMID: 30816640 [PubMed - as supplied by publisher]