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A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804

A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804)

NCT03118570•Ultragenyx Pharmaceutical Inc

View on ClinicalTrials.gov

Summary

The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.

Detailed Description

This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a clinical diagnosis of OI Type I, III or IV with a confirmed defect in the COL1A1/COL1A2 genes, as confirmed by genetic testing
•One or more fractures in the past 5 years
•Capable of giving signed consent

Exclusion Criteria

•History of skeletal malignancies or other bone diseases (other than OI)
•History of neural foraminal stenosis (except if due to scoliosis)
•History of myocardial infarction, angina pectoris, ischaemic stroke or transient ischaemic attack
•History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
•Treatment with bisphosphonates within 3 months of randomisation
•Treatment with teraparatide, denosumab or other anabolic/anti-reabsorptive medications within 6 months of randomisation

Locations (25)

Mereo Investigator Site

Birmingham, Alabama, United States

Mereo Investigator Site

Jacksonville, Florida, United States

Mereo Investigator Site

Baltimore, Maryland, United States

Mereo Investigator Site

Boston, Massachusetts, United States

Mereo Investigator Site

Saint Paul, Minnesota, United States

Mereo Investigator Site

St Louis, Missouri, United States

Mereo Investigator Site

Albuquerque, New Mexico, United States

Mereo Investigator Site

Cincinnati, Ohio, United States

Mereo Investigator Site

Portland, Oregon, United States

Mereo Investigator Site

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

September 11, 2017

Primary Completion Date

October 1, 2019

Completion Date

November 12, 2020

Last Updated

July 5, 2023

Enrollment

112

ACTUAL participants

Conditions

Osteogenesis Imperfecta, Type IOsteogenesis Imperfecta Type IIIOsteogenesis Imperfecta Type IV

Interventions

setrusumab

DRUG

Calcium

DIETARY_SUPPLEMENT

Vitamin D

DIETARY_SUPPLEMENT

zoledronic acid (optional)

DRUG

Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)

NCT05559801

Osteogenesis ImperfectaOsteogenesis Imperfecta Type III

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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