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Comparing Denosumab Biosimilar GP2411 and Reference Denosumab in Postmenopausal Osteoporosis
April 2025
Comparing Denosumab Biosimilar GP2411 and Reference Denosumab in Postmenopausal Osteoporosis
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:1
Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study.
J Bone Miner Res. 2024 Apr 19;39(3):202-210.Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
Five hundred twenty-seven postmenopausal women with osteoporosis were randomized to receive either biosimilar denosumab GP2411 (n=263) or reference denosumab (n=264), with doses administered at baseline and week 26. At week 52, participants initially treated with reference denosumab were re-randomized to continue reference denosumab or switch to GP2411. The primary outcome was the percent change f...
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