Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | June 2011 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +41 61 324 1111 |
A Randomized, Open Label Intra-patient Dose Escalation Study With an Untreated Reference Group to Evaluate Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Infusions of BPS804 in Adults With Moderate 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 addition, tolerability and pharmacokinetics (PK) will be evaluated.
Twelve to 15 patients will be enrolled.
Inclusion Criteria:
- Osteogenesis imperfecta
- Two or more previous fractures
- Bone mineral density Z-score of ≤ -1.0 and > -4.0
Exclusion Criteria:
- 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
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