Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
Summary
This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.
Timeline
- Start
- 2012-03-28
- Primary completion
- 2016-06-21
- Completion
- 2017-06-29
Outcome
Met primary endpoint
registry analysis (non-inferiority test); Risedronate: Glucocorticoid-initiating vs Denosumab: Glucocorticoid-initiating; p < 0.001; LS Mean Difference 2.9 (95% CI 2.0 to 3.9) NCT01575873 ↗
paper Denosumab was superior to risedronate in increasing lumbar spine and total hip BMD at all time points assessed, among glucocorticoid-initiating patients PMID 30816640 ↗
release “a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment met primary and secondary endpoints at 12 months.” amgen.com ↗
release “study evaluating the safety and efficacy of Prolia ® (denosumab) compared with risedronate in patients receiving glucocorticoid treatment. The study met all primary and secondary endpoints” amgen.com ↗
release “In August, a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment met primary and secondary endpoints at 12 months.” amgen.com ↗
Publications
- Background Saag KG, Wagman RB, Geusens P, Adachi JD, Messina OD, Emkey R, Chapurlat R, Wang A, Pannacciulli N, Lems WF. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):445-454. doi: 10.1016/S2213-8587(18)30075-5. Epub 2018 Apr 6.
- Saag KG, Pannacciulli N, Geusens P, Adachi JD, Messina OD, Morales-Torres J, Emkey R, Butler PW, Yin X, Lems WF. Denosumab Versus Risedronate in Glucocorticoid-Induced Osteoporosis: Final Results of a Twenty-Four-Month Randomized, Double-Blind, Double-Dummy Trial. Arthritis Rheumatol. 2019 Jul;71(7):1174-1184. doi: 10.1002/art.40874. Epub 2019 May 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 60 mg | Subcutaneous |
| Subject | Risedronate | Small molecule | 5 mg | Oral |