Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
NCT ID: NCT01417091
Last Updated: 2021-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2011-06-30
2012-12-31
Brief Summary
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Pharmacodynamic effect will be determined by serological biomarkers and radiologic assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group
BPS804
Untreated reference group
No interventions assigned to this group
Interventions
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BPS804
Eligibility Criteria
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Inclusion Criteria
* Two or more previous fractures
* Bone mineral density Z-score of ≤ -1.0 and \> -4.0
Exclusion Criteria
* Fracture within last 2 weeks
* Treatment with bisphosphonates/teriparatide (last 6 months)
* Surgery within last year
18 Years
75 Years
ALL
No
Sponsors
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Ultragenyx Pharmaceutical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Ultragenyx Pharmaceutical Inc
Locations
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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
Countries
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References
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Glorieux FH. Osteogenesis imperfecta. Best Pract Res Clin Rheumatol. 2008 Mar;22(1):85-100. doi: 10.1016/j.berh.2007.12.012.
Other Identifiers
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2011-001465-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBPS804A2201
Identifier Type: -
Identifier Source: org_study_id
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