Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

Summary

This is a randomized, double-blind, parallel design, repeat dose, 2 arm, multicenter study comparing the efficacy, safety, immunogenicity, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of AVT03 and US-Prolia in postmenopausal women with osteoporosis.

Timeline

Start

2022-08-23

Primary completion

2024-05-07

Completion

2024-10-28

Publications

• Lortkipanidze M, de Villiers T, Kania G, Bullo F, Jaskiewicz L, Stamatakos S, Rai M, Haliduola H, Otto H, Sattar A, Leutz S, Berti F. A randomized, double blind, parallel design, repeat dose, 2-arm, multicenter study comparing the efficacy, safety, immunogenicity, and pharmacokinetic profiles of a denosumab biosimilar, AVT03, in postmenopausal women with osteoporosis. Expert Opin Biol Ther. 2025 Aug;25(8):899-912. doi: 10.1080/14712598.2025.2538609. Epub 2025 Jul 28.

Drugs

Indications