WithdrawnPhase 2

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

Stopped: Administrative Reason

United States0Started 2017-10-31

Plain-language 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.

Who can participate

Age range18 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 * 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

What they're measuring

Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)

Timeframe: 12 months

Change in radial bone strength on Finite Element Analysis (N)

Timeframe: 12 months

Trial details

NCT IDNCT03216486

SponsorUltragenyx Pharmaceutical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-01

View on ClinicalTrials.gov More Osteogenesis Imperfecta trials