An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta

Osteogenesis Imperfecta Clinical Trial

— Meteoroid  

Official title:

A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03216486
• Other study ID #: MBPS208
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 31, 2017
• Est. completion date: November 1, 2018

Study information

• Verified date: June 2023
• Source: Ultragenyx Pharmaceutical Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a clinical diagnosis of OI Type I, III or IV
• Capable of giving signed consent

Exclusion Criteria:

• History of skeletal malignancies or other bone diseases (other than OI)
• History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
• Treatment with bisphosphonates within 3 months of randomisation
• Treatment with teraparatide, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Drug:
• BPS804
IV administration of BPS804 in 5% Dextrose solution

Locations

Country	Name	City	State
United States	Mereo Investigator Site	Albuquerque	New Mexico
United States	Mereo Investigator Site	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Ultragenyx Pharmaceutical Inc	Mereo BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)	High Resolution Peripheral Quantitative Computated Tomography	12 months
Primary	Change in radial bone strength on Finite Element Analysis (N)	High Resolution Peripheral Quantitative Computated Tomography	12 months
Secondary	Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)	High Resolution Peripheral Quantitative Computated Tomography	12 months
Secondary	Change in tibial bone strength on Finite Element Analysis (N)	High Resolution Peripheral Quantitative Computated Tomography	12 months