Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05768854 · ClinicalTrials.gov registry record · Phase 3

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta

A Phase 3 study of Osteogenesis Imperfecta, sponsored by Ultragenyx Pharmaceutical.

Active
Registry status
Phase 3
Development phase
69
Enrollment target
20
Study locations

NCT05768854 is a Phase 3 study of Osteogenesis Imperfecta that is active but no longer recruiting, run by Ultragenyx Pharmaceutical. The registered enrollment target is 69 participants, below the 156-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 15 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05768854, a Phase 3 study of Osteogenesis Imperfecta, is active but no longer recruiting, sponsored by Ultragenyx Pharmaceutical.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
69 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.

Conditions Studied

Osteogenesis Imperfecta

Interventions

  • DRUG Bisphosphonate
  • BIOLOGICAL Setrusumab

Study Locations (20)

Other

  • Childrens Hospital Of Eastern Ontario Research Institute, University Of Ottawa - Ottawa
  • Institut Imagine - Paris
  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Roma
  • Universitair Medisch Centrum Utrecht (UMCU) - Wilhelmina Kinderziekenhuis - Utrecht
  • Uniwersytet Medyczny w Lodzi - Klinika Endokrynologii i Chorob Metabolicznych - Lodz

Texas

  • Cook Children's Medical Center - Fort Worth
  • Baylor College of Medicine - Houston

Arizona

  • Phoenix Children's Hospital - Phoenix

California

  • Childrens Hospital LA - Los Angeles

Colorado

  • Children's Hospital Colorado - Aurora

Connecticut

  • Yale New Haven Hospital - New Haven

Delaware

  • Nemours/ Alfred i. duPoint Hospital for Children - Wilmington

District of Columbia

  • Children's National Hospital DC - Washington D.C.

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2023-06-14
Est. Completion 2027-04
Phase Phase 3

Sponsor

Ultragenyx Pharmaceutical

52 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05768854

The ClinicalTrials.gov registry entry for NCT05768854 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 156-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (56% lower). The listed sponsor is Ultragenyx Pharmaceutical, which has 52 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.

NCT05768854 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, Texas, Arizona.

Frequently Asked Questions

What is clinical trial NCT05768854 about?

NCT05768854 is a clinical study titled "Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta". The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.

What is the current status of trial NCT05768854?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2023-06-14. Estimated completion is 2027-04.

What conditions does trial NCT05768854 study?

This clinical trial studies the following conditions: Osteogenesis Imperfecta.

What interventions are being tested in trial NCT05768854?

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

Who is sponsoring clinical trial NCT05768854?

This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05768854 being conducted?

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

Learn More About Clinical Trials

Similar trials for Osteogenesis Imperfecta

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Osteogenesis Imperfecta

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
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.