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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2018-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03118570

Osteogenesis Imperfecta, Type I Osteogenesis Imperfecta Type III Osteogenesis Imperfecta Type IV

COMPLETED PHASE2

Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta

NCT01417091

Osteogenesis Imperfecta

COMPLETED PHASE2

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

NCT05972551

Osteogenesis Imperfecta

RECRUITING PHASE3

Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density

NCT01406548

Osteopenia Osteoporosis

COMPLETED PHASE2

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta

NCT05768854

Osteogenesis Imperfecta

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteogenesis Imperfecta

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm, open-label

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BPS804 Dose 1

BPS804 IV Infusion

Group Type EXPERIMENTAL

BPS804

Intervention Type DRUG

IV administration of BPS804 in 5% Dextrose solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BPS804

IV administration of BPS804 in 5% Dextrose solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No