NCT03216486

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

July 12, 2017

Last Update Submit

June 29, 2023

Conditions

Osteogenesis Imperfecta

Outcome Measures

Primary Outcomes (2)

  • Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)

    High Resolution Peripheral Quantitative Computated Tomography

    12 months

  • Change in radial bone strength on Finite Element Analysis (N)

    High Resolution Peripheral Quantitative Computated Tomography

    12 months

Secondary Outcomes (2)

  • Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)

    12 months

  • Change in tibial bone strength on Finite Element Analysis (N)

    12 months

Study Arms (1)

BPS804 Dose 1

EXPERIMENTAL

BPS804 IV Infusion

Drug: BPS804

Interventions

BPS804DRUG

IV administration of BPS804 in 5% Dextrose solution

BPS804 Dose 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mereo Investigator Site

Albuquerque, New Mexico, 87106, United States

Location

Mereo Investigator Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Osteogenesis Imperfecta

Interventions

setrusumab

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Medical Director

    Ultragenyx Pharmaceutical Inc

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm, open-label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 13, 2017

Study Start

October 31, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations

US(2)