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

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteogenesis Imperfecta, Type I, Osteogenesis Imperfecta Type III, Osteogenesis Imperfecta Type IV

In brief

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.

Key facts

Study ID

NCT03118570

Run by

Ultragenyx Pharmaceutical Inc

People needed

112

Starts

2017-09-11

Expected to finish

2020-11-12

Last updated by the study team

2023-07-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Mereo Investigator Site — Nashville, Tennessee, United States
• Mereo Investigator Site — Houston, Texas, United States
• Mereo Investigator Site — Toronto, Ontario, Canada
• Mereo Investigator Site — Montreal, Quebec, Canada
• Mereo Investigator Site — Québec, Quebec, Canada
• Mereo Investigator Site — Aarhus, Denmark
• Mereo Investigator Site — Odense, Denmark
• Mereo Investigator Site — Paris, Paris Cedex 14, France
• Mereo Investigator Site — Lyon, France
• Mereo Investigator Site — Paris, France
• Mereo Investigator Site — Cambridge, Cambridgeshire, United Kingdom
• Mereo Investigator Site — Newcastle upon Tyne, Newcastle, United Kingdom
• Mereo Investigator Site — Oxford, Oxfordshire, United Kingdom
• Mereo Investigator Site — Bristol, United Kingdom
• Mereo Investigator Site — London, United Kingdom

Full record on ClinicalTrials.gov

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