An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta (Meteoroid)

Ultragenyx

Status and phase: Withdrawn; Phase 2

Conditions: Osteogenesis Imperfecta

Treatments: Drug: BPS804

Study type: Interventional

Funder types: Industry

Identifiers

NCT03216486

MBPS208

Details and patient eligibility

About

The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.

Full description

This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a clinical diagnosis of OI Type I, III or IV
• Capable of giving signed consent

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

BPS804 Dose 1

Experimental group

Description:

BPS804 IV Infusion

Treatment:

Drug: BPS804