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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00131118
• Date of registration: 15/08/2005
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
• Scientific title: Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
• Date of first enrolment: July 2004
• Target sample size: 127
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00131118
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

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.



Age minimum: 1 Year
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteogenesis Imperfecta

Intervention(s)

Drug: Zoledronic Acid

Primary Outcome(s)

Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202

Secondary Outcome(s)

Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.

Secondary ID(s)

CZOL446H2202E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors