Status:
COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
Lead Sponsor:
Ultragenyx Pharmaceutical Inc
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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). ...
Detailed Description
This study was previously posted by Mereo BioPharma and was transferred to Ultragenyx in February 2021.
Eligibility Criteria
Inclusion
- Osteogenesis imperfecta
- Two or more previous fractures
- Bone mineral density Z-score of ≤ -1.0 and \> -4.0
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01417091
Start Date
June 1 2011
End Date
December 1 2012
Last Update
May 11 2021
Active Locations (6)
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1
Novartis Investigative Site
Anaheim, California, United States, 92801
2
Novartis Investigative Site
Miramar, Florida, United States, 33025
3
Novartis Investigative Site
Brussels, Belgium, 1200
4
Novartis Investigative Site
Ghent, Belgium, 9000