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

Status:	Active, not recruiting
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	18 - 75
Updated:	3/16/2019
Start Date:	September 11, 2017
End Date:	October 31, 2020

Protocol Title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804).

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.

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

We found this trial at

sites

Mereo Investigator Site

Toronto, Ontario

from

Toronto,