Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

Novartis

Status and phase: Completed; Phase 2

Conditions: Osteogenesis Imperfecta

Treatments: Drug: Zoledronic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00131118

CZOL446H2202E1

Details and patient eligibility

About

This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed the core CZOL446H2202 study
• Males or females between 1-17 years of age

Exclusion criteria

• 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)