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Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND — ALVOBOND  

Osteoporosis, Postmenopausal Clinical Trial

Official title:
A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopausal Women With Osteoporosis, ALVOBOND

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

Clinical Trial Details
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
View Details
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