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Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND

NCT05395091 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2025-05-29

Study results available
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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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

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.

Sponsors & Collaborators

  • Alvotech Swiss AG

    lead INDUSTRY

Principal Investigators

  • Felicitas Bullo · Alvotech Swiss AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2024-05-07
Completion
2024-10-28
FDA Drug
Yes

Countries

  • Bulgaria
  • Czechia
  • Georgia
  • Poland
  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05395091 on ClinicalTrials.gov