Bisphosphonate Treatment of Osteogenesis Imperfecta

Novartis

Status and phase: Completed; Phase 2

Conditions: Osteogenesis Imperfecta

Treatments: Drug: Zoledronic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00063479

CZOL446H2202

Details and patient eligibility

About

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.

Sex: All

Ages: 3 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)