Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study

Denosumab is a monoclonal antibody used to reduce risk of fractures in osteoporosis. ROSALIA was a multicenter, double-blind, randomized, integrated phase I/phase III study comparing the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of proposed biosimilar denosum...

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Veröffentlicht in:	Journal of bone and mineral research 2024-04, Vol.39 (3), p.202-210
Hauptverfasser:	Jeka, Sławomir, Dokoupilová, Eva, Kivitz, Alan, Żuchowski, Paweł, Vogg, Barbara, Krivtsova, Natalia, Sekhar, Susmit, Banerjee, Samik, Schwebig, Arnd, Poetzl, Johann, Body, Jean-Jacques, Eastell, Richard
Format:	Artikel
Sprache:	eng
Schlagworte:	Biosimilar Pharmaceuticals - adverse effects Bone Density Bone Density Conservation Agents - therapeutic use Clinical Trial Denosumab - adverse effects Double-Blind Method Female Humans Osteoporosis - drug therapy Osteoporosis, Postmenopausal - drug therapy
Online-Zugang:	Volltext
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