Bisphosphonate Treatment of Osteogenesis Imperfecta

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00063479
• Date of registration: 27/06/2003
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Bisphosphonate Treatment of Osteogenesis Imperfecta
• Scientific title: Bisphosphonate Treatment of Osteogenesis Imperfecta
• Date of first enrolment: June 2003
• Target sample size: 158
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00063479
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany, United States

Key inclusion & 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.



Age minimum: 3 Months
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteogenesis Imperfecta

Intervention(s)

Drug: Zoledronic Acid

Primary Outcome(s)

Change in lumbar spine bone mineral density at month 12 relative to baseline

Secondary Outcome(s)

Change in Z score of the lumbar spine at month 12 relative to baseline

Secondary ID(s)

CZOL446H2202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors