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Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

NCT04545554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-04-15

Study results available
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Summary

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).

Conditions

Interventions

DRUG

Romosozumab

Participants will receive multiple doses of romosozumab via a SC injection.

DIETARY_SUPPLEMENT

Calcium

All participants will receive daily supplements of elemental calcium.

DIETARY_SUPPLEMENT

Vitamin D

All participants will receive daily supplementation with vitamin D.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2023-03-30
Completion
2023-03-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Germany
  • Greece
  • Hungary
  • Italy
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT04545554 on ClinicalTrials.gov