NCT05395091COMPLETEDanonymous

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

Sponsor

Source record

Alvotech Swiss AG

Phase

Source record

PHASE3

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Osteoporosis, Postmenopausal

Indication / condition

AI-normalized

Osteoporosis, Postmenopausal

Intervention

Source record

AVT03, Denosumab

Related intelligence directories

Indication directory: Osteoporosis Modality directory: monoclonal antibody Target directory: Osteoporosis

Source & freshness

Source record

NCT ID

NCT05395091

Original source

ClinicalTrials.gov

Source last updated

May 29, 2025

Ingested at

Jun 03, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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NCT ID

NCT05395091

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

Sponsor

Alvotech Swiss AG

Status

COMPLETED

Phase

PHASE3

Condition raw

Osteoporosis, Postmenopausal

Condition normalized

Osteoporosis, Postmenopausal

Modality raw

Osteoporosis, Postmenopausal

Modality normalized

monoclonal antibody

Target raw

Osteoporosis, Postmenopausal

Target normalized

Osteoporosis, Postmenopausal

Interventions

AVT03, Denosumab

Public preview

Source record

The ALVOBOND study evaluates AVT03, a proposed biosimilar to Prolia (denosumab), in postmenopausal women with osteoporosis. The trial aims to demonstrate comparable efficacy, safety, immunogenicity, and pharmacokinetic profiles between AVT03 and Prolia. The study completed enrollment of 532 participants across multiple countries.

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Investment-Ready Snapshot

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

Source & freshness

Public preview

Create an account to unlock this report

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

Investment-Ready Snapshot

Provenance

Protocol Description

Outcome Measures

Eligibility

Known Results And Readout Context

Patent And IP Landscape

Contacts