Denosumab vs risedronate in glucocorticoid-induced osteoporosis: final results of a 24-month randomized, double-blind, double-dummy trial

Arthritis & Rheumatology
Kenneth G SaagWillem F Lems

Abstract

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. 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. 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 ...Continue Reading

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Methods Mentioned

BETA
contraception

Clinical Trials Mentioned

NCT01575873

Software Mentioned

BioClinica
Genant

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