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Clinical Trial 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.


Clinical Trial Description

After the screening activities, eligible subjects were randomized to receive either AVT03 60 mg or Prolia® 60 mg, administered as a subcutaneous (s.c.) injection At Month 12, subjects in AVT03 treatment group will receive a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will be re-randomized to receive either Prolia 60 mg or AVT03 60 mg administered as a subcutaneous injection. Afterwards, the subjects will be followed until the End of Study (EoS) Visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05395091
Study type Interventional
Source Alvotech Swiss AG
Contact
Status Active, not recruiting
Phase Phase 3
Start date August 23, 2022
Completion date October 25, 2024

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