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

• Status: Completed
• Trial end date: 2020-11-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mereo BioPharma; Ultragenyx Pharmaceutical Inc
• Collaborator: ICON Clinical Research

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation