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NCT05972551 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

A Phase 3 study of Osteogenesis Imperfecta, sponsored by Amgen.

Recruiting
Registry status
Phase 3
Development phase
106
Enrollment target
20
Study locations

NCT05972551 is a Phase 3 study of Osteogenesis Imperfecta that is actively recruiting participants, run by Amgen. The registered enrollment target is 106 participants, below the 153-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05972551, a Phase 3 study of Osteogenesis Imperfecta, is actively recruiting participants, sponsored by Amgen.

RECRUITING
Registry status
Phase 3
Development phase
106 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.

Conditions Studied

Osteogenesis Imperfecta

Interventions

  • DRUG Bisphosphonate
  • DRUG Romosozumab

Study Locations (20)

Florida

  • Nemours Childrens Hospital - Orlando
  • University of South Florida - Carol and Frank Morsani Center for Advanced Health Care - Tampa

Minnesota

  • Mayo Clinic Childrens Center - Rochester
  • Gillette Childrens Hospital and Clinic Saint Paul - Saint Paul

Other

  • Kepler Universitaetsklinikum GmbH - Linz
  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg - Leuven

Ontario

  • Childrens Hospital of Eastern Ontario - Ottawa
  • The Hospital for Sick Children - Toronto

Alabama

  • Childrens Hospital of Alabama - Birmingham

Arizona

  • Phoenix Childrens Hospital - Phoenix

California

  • University of California, Los Angeles Interventional Clinical Trials - Los Angeles

Delaware

  • Nemours Hospital for Children - Wilmington

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2024-04-22
Est. Completion 2027-08-25
Phase Phase 3

Sponsor

Amgen

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05972551

The ClinicalTrials.gov registry entry for NCT05972551 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 153-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (31% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Osteogenesis Imperfecta appearing as the primary indexed condition, and to 2 interventions - of which Bisphosphonate is the first listed.

NCT05972551 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Florida, Minnesota, Other.

Frequently Asked Questions

What is clinical trial NCT05972551 about?

NCT05972551 is a clinical study titled "Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta". The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.

What is the current status of trial NCT05972551?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2024-04-22. Estimated completion is 2027-08-25.

What conditions does trial NCT05972551 study?

This clinical trial studies the following conditions: Osteogenesis Imperfecta.

What interventions are being tested in trial NCT05972551?

The interventions under investigation include: Bisphosphonate (DRUG), Romosozumab (DRUG).

Who is sponsoring clinical trial NCT05972551?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05972551 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.