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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

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

Open original registry record
View original source fields

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.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence 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

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT05395091

Status

COMPLETED

Phase

PHASE3

Sponsor

Alvotech Swiss AG

Executive brief

Investment-Ready Snapshot

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.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedMay 29, 2025
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05395091

Indication

Osteoporosis, Postmenopausal

Modality

monoclonal antibody

Target

Osteoporosis, Postmenopausal

Intervention

AVT03, Denosumab

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.