Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta

Completed · Phase 2

Conditions studied: Osteogenesis Imperfecta

In brief

This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI). Pharmacodynamic effect will be determined by serological biomarkers and radiologic assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.

Key facts

Study ID

NCT01417091

Run by

Ultragenyx Pharmaceutical Inc

People needed

10

Starts

2011-06-01

Expected to finish

2012-12-01

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Osteogenesis imperfecta
• Two or more previous fractures
• Bone mineral density Z-score of ≤ -1.0 and > -4.0

You may not qualify if…

• Open epiphyses
• Fracture within last 2 weeks
• Treatment with bisphosphonates/teriparatide (last 6 months)
• Surgery within last year
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Anaheim, California, United States
• Novartis Investigative Site — Miramar, Florida, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Würzburg, Germany

Full record on ClinicalTrials.gov

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