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

NCT03118570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-07-05

Study results available
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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.

Conditions

  • Osteogenesis Imperfecta, Type I
  • Osteogenesis Imperfecta Type III
  • Osteogenesis Imperfecta Type IV

Interventions

DRUG

setrusumab

Intravenous infusion

DIETARY_SUPPLEMENT

Calcium

tablets

DIETARY_SUPPLEMENT

Vitamin D

capsules

DRUG

zoledronic acid (optional)

Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Mereo BioPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2019-10-01
Completion
2020-11-12
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03118570 on ClinicalTrials.gov