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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to select a suitable dose of BPS804 by comparing it with a dummy treatment and measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 1 year.

Official Title

A Phase 2b Study, Multicentre, Multinational, Placebo-controlled, Double-blind, Dose-finding Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804

Keywords

Osteogenesis Imperfecta, Type I Osteogenesis Imperfecta Type III Osteogenesis Imperfecta Type IV Osteogenesis Imperfecta Brittle Bone Disease

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 24 months
  • Capable of giving signed consent

You CAN'T join 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

Locations

  • Mereo Investigator Site not yet accepting patients
    Portland, Oregon, 97239, United States
  • Mereo Investigator Site accepting new patients
    Albuquerque, New Mexico, 87106, United States
  • Mereo Investigator Site not yet accepting patients
    Houston, Texas, 77030, United States
  • Mereo Investigator Site not yet accepting patients
    Saint Paul, Minnesota, 55101, United States
  • Mereo Investigator Site not yet accepting patients
    Saint Louis, Missouri, 63110, United States
  • Mereo Investigator Site not yet accepting patients
    Nashville, Tennessee, 37232, United States
  • Mereo Investigator Site not yet accepting patients
    Birmingham, Alabama, 35294, United States
  • Mereo Investigator Site not yet accepting patients
    Toronto, Ontario, Canada
  • Mereo Investigator Site not yet accepting patients
    Cincinnati, Ohio, 45229, United States
  • Mereo Investigator Site not yet accepting patients
    Pittsburgh, Pennsylvania, 15225, United States
  • Mereo Investigator Site not yet accepting patients
    Jacksonville, Florida, 32207, United States
  • Mereo Investigator Site not yet accepting patients
    Baltimore, Maryland, 21287, United States
  • Mereo Investigator Site not yet accepting patients
    Philadelphia, Pennsylvania, 19104, United States
  • Mereo Investigator Site not yet accepting patients
    Montreal, Quebec, Canada
  • Mereo Investigator Site not yet accepting patients
    Quebec City, Quebec, Canada
  • Mereo Investigator Site not yet accepting patients
    Boston, Massachusetts, 012115, United States
  • Mereo Investigator Site not yet accepting patients
    Cambridge, Cambridgeshire, United Kingdom
  • Mereo Investigator Site not yet accepting patients
    Newcastle upon Tyne, Newcastle, United Kingdom
  • Mereo Investigator Site not yet accepting patients
    Oxford, Oxfordshire, United Kingdom
  • Mereo Investigator Site not yet accepting patients
    Bristol, United Kingdom
  • Mereo Investigator Site not yet accepting patients
    London, United Kingdom
  • Mereo Investigator Site not yet accepting patients
    Aarhus, Denmark
  • Mereo Investigator Site not yet accepting patients
    Odense, Denmark
  • Mereo Investigator Site not yet accepting patients
    Paris, Paris Cedex 14, France
  • Mereo Investigator Site not yet accepting patients
    Lyon, France
  • Mereo Investigator Site not yet accepting patients
    Paris, France

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mereo BioPharma
Links
Study Website
ID
NCT03118570
Phase
Phase 2
Study Type
Interventional
Last Updated
May 1, 2017
I’m interested in this study!