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: Active Phase 3 study of Osteogenesis Imperfecta, sponsored by Ultragenyx Pharmaceutical.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2023-06-14 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
What the registry record for NCT05768854 still lists
NCT05768854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 156-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (56% lower).
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 names 20 study sites across 15 states, led by 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.
Where NCT05768854's enrollment target sits among peer trials
69 9th of 13 higher than 5 of 13 other Osteogenesis Imperfecta trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteogenesis Imperfecta trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
RECRUITING · Phase 3
-
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
COMPLETED · Phase 3
-
Growth Hormone Therapy in Osteogenesis Imperfecta
COMPLETED · Phase 3
-
Effects of Bisphosphonates on OI-Related Hearing Loss
RECRUITING · Phase 4
-
BBD Longitudinal Study of Osteogenesis Imperfecta
RECRUITING
-
Setrusumab vs Placebo for Osteogenesis Imperfecta
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04020575 · 69 participants · Phase 1
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
- NCT04163614 · 69 participants · NA
Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
- NCT04164641 · 69 participants · NA
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration
- NCT04493372 · 69 participants · NA
Deciphering Preserved Autonomic Function After Spinal Cord Injury
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI