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

A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03216486

Acronym

Meteoroid

Enrollment

Registered

2017-07-13

Start date

2017-10-31

Completion date

2018-11-01

Last updated

2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteogenesis Imperfecta

Brief summary

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.

Detailed description

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

Interventions

DRUGBPS804

IV administration of BPS804 in 5% Dextrose solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single arm, open-label

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)	12 months	High Resolution Peripheral Quantitative Computated Tomography
Change in radial bone strength on Finite Element Analysis (N)	12 months	High Resolution Peripheral Quantitative Computated Tomography

Secondary

Measure	Time frame	Description
Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)	12 months	High Resolution Peripheral Quantitative Computated Tomography
Change in tibial bone strength on Finite Element Analysis (N)	12 months	High Resolution Peripheral Quantitative Computated Tomography

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026