NCT05395091

Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 532 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 on Day 1 and at Month 6. At Month 12, subjects in AVT03 treatment group will received a third dose of AVT03 60 mg administered s.c. while subjects in Prolia® treatment group will were be re-randomized 1:1 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.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
BIOLOGICAL	AVT03	AVT03 (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL to be administered as a subcutaneous injection. Subjects in this arm received AVT03 60mg administered s.c. on Day 1 and at Month 6. At Month 12, subjects in the AVT03 arm received a third dose of AVT03 60 mg.
BIOLOGICAL	Denosumab	Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection. Subjects in this arm received 60mg of commercially available US-Prolia, administered s.c on Day 1 and at Month 6. At Month 12, subjects in the Prolia treatment group were re-randomized in a 1:1 ratio to receive either: * AVT03 60 mg administered s.c. on Day365. * Prolia 60 mg administered s.c. on Day365.

Timeline

• Start date: 2022-08-23
• Primary completion: 2024-05-07
• Completion: 2024-10-28
• First posted: 2022-05-27
• Last updated: 2025-05-29
• Results posted: 2025-05-29

Locations

34 sites across 5 countries: Bulgaria, Czechia, Georgia, Poland, South Africa

Regulatory

• FDA-regulated drug study