Bisphosphonate Treatment of Osteogenesis Imperfecta

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion

• Male or Female children between 3 months and 17 years old

• OI type I, III or IV

Exclusion

• Deformity or abnormality which would prevent spine bone density from being done

• Any surgical bone-lengthening procedure

• Any kidney diseases or abnormalities

• Low calcium or vitamin D levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.