Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01417091 · ClinicalTrials.gov registry record · Phase 2
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
A Phase 2 study of Osteogenesis Imperfecta, sponsored by Ultragenyx Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 6
- Study locations
NCT01417091: Completed Phase 2 study of Osteogenesis Imperfecta, sponsored by Ultragenyx Pharmaceutical.
NCT01417091 is a Phase 2 study of Osteogenesis Imperfecta that has completed, run by Ultragenyx Pharmaceutical. The registered enrollment target is 10 participants, below the 160-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01417091, a Phase 2 study of Osteogenesis Imperfecta, has completed, sponsored by Ultragenyx Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 6
- Study locations
Study 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). Pharmacodynamic effect will be determined by serological biomarkers and radiologic assessments. In addition, tolerability and pharmacokinetics (PK) will be evaluated.
Primary Outcome
The assessment of safety will be based on primarily on the frequency of adverse events, laboratory abnormalities, and serious adverse events suspected by the investigators to be related to study treatments. The AE collection period extends from the time of first study drug administration drug until study completion. The intensity of each AE will be characterized and classified into 1 of the 3 generic categories (mild, moderate, or severe). The number and percentage of patients with adverse event
Conditions Studied
Interventions
- DRUG BPS804
Study Locations (6)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Ghent
- Novartis Investigative Site - Würzburg
California
- Novartis Investigative Site - Anaheim
Florida
- Novartis Investigative Site - Miramar
Quebec
- Novartis Investigative Site - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01417091 record still lists
NCT01417091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 160-participant average among 13 other Osteogenesis Imperfecta trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Osteogenesis Imperfecta appearing as the primary indexed condition, and to 1 intervention - of which BPS804 is the first listed.
NCT01417091 lists 6 locations in 4 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT01417091 about?
NCT01417091 is a clinical study titled "Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta". 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 ...
What is the current status of trial NCT01417091?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-06. Estimated completion is 2012-12.
What conditions does trial NCT01417091 study?
This clinical trial studies the following conditions: Osteogenesis Imperfecta.
What interventions are being tested in trial NCT01417091?
The interventions under investigation include: BPS804 (DRUG).
Who is sponsoring clinical trial NCT01417091?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01417091 being conducted?
This trial has 6 study locations across California, Florida, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteogenesis Imperfecta
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01417091's enrollment target sits among peer trials
10 14th of 13 the lowest of 13 other Osteogenesis Imperfecta trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteogenesis Imperfecta trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Setrusumab vs Placebo for Osteogenesis Imperfecta
ACTIVE NOT RECRUITING · Phase 2
-
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
RECRUITING · Phase 3
-
Effects of Bisphosphonates on OI-Related Hearing Loss
RECRUITING · Phase 4
-
BBD Longitudinal Study of Osteogenesis Imperfecta
RECRUITING
-
Urinary Biomarkers of OI Pathobiology
ACTIVE NOT RECRUITING
-
Clear Aligners for the Treatment of Dental Malocclusion in OI
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia