NCT04545554COMPLETEDanonymous

An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

Sponsor

Source record

Amgen

Phase

Source record

PHASE1

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Romosozumab, Calcium, Vitamin D

Indication / condition

AI-normalized

Osteogenesis Imperfecta

Intervention

Source record

Romosozumab, Calcium, Vitamin D

Source & freshness

Source record

NCT ID

NCT04545554

Original source

ClinicalTrials.gov

Source last updated

Apr 15, 2024

Ingested at

Jun 11, 2026

Internal sync

Jun 11, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record

View original source fields

NCT ID

NCT04545554

Title

An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

Sponsor

Amgen

Status

COMPLETED

Phase

PHASE1

Condition raw

Osteogenesis Imperfecta

Condition normalized

Osteogenesis Imperfecta

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Romosozumab, Calcium, Vitamin D

Target normalized

Romosozumab, Calcium, Vitamin D

Interventions

Romosozumab, Calcium, Vitamin D

Public preview

Source record

The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).

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

An Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

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

Generated

Jun 13, 2026

NCT ID

NCT04545554

Status

COMPLETED

Phase

PHASE1

Sponsor

Amgen

Executive brief

Investment-Ready Snapshot

Source & freshness

Provenance

SourceClinicalTrials.gov

Source updatedApr 15, 2024

Internal syncJun 11, 2026

Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT04545554

Indication

Osteogenesis Imperfecta

Modality

monoclonal antibody

Target

Romosozumab, Calcium, Vitamin D

Intervention

Romosozumab, Calcium, Vitamin D

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.