CompletedPhase 2

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

United States112 participantsStarted 2017-09-11

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, denosumab or other anabolic/anti-reabsorptive medications within 6 months of randomisation

What they're measuring

Change From Baseline in Radial Trabecular Volumetric Bone Mineral Density (Tr vBMD) at Month 12

Timeframe: Baseline, Month 12 (end of treatment [EOT])

Change From Baseline in Radial Bone Strength (Failure Load) at Month 12

Timeframe: Baseline, Month 12 (EOT)

Change From Baseline in Radial Bone Strength (Stiffness) at Month 12

Timeframe: Baseline, Month 12 (EOT)

Trial details

NCT IDNCT03118570

SponsorUltragenyx Pharmaceutical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-01

Results submitted2021-12-13

View on ClinicalTrials.gov More Osteogenesis Imperfecta, Type I trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Radial Trabecular Volumetric Bone Mineral Density (Tr vBMD) at Month 12

Timeframe: Baseline, Month 12 (end of treatment [EOT])

Change From Baseline in Radial Bone Strength (Failure Load) at Month 12

Timeframe: Baseline, Month 12 (EOT)

Change From Baseline in Radial Bone Strength (Stiffness) at Month 12

Timeframe: Baseline, Month 12 (EOT)