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Arthritis Rheumatol. 2019 Feb 28. doi: 10.1002/art.40874. [Epub ahead of print]

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

Author information

Department of Medicine, University of Alabama at Birmingham, Birmingham, AL.
Research and Development, Amgen Inc., Thousand Oaks, CA.
Department of Internal Medicine, Maastricht University, Maastricht, Netherlands.
Department of Medicine, McMaster University, Hamilton, ON, Canada.
Department of Rheumatology, Cosme Argerich Hospital, Buenos Aires, Argentina.
Department of Rheumatology, Hospital Aranda de la Parra, Leon, Mexico.
Clinical Research, Emkey Arthritis & Osteoporosis Clinic, Wyomissing, PA.
Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, Netherlands.



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 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.


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.


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