Status:
COMPLETED
Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Osteogenesis Imperfecta
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Have completed the core CZOL446H2202 study
- Males or females between 1-17 years of age
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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00131118
Start Date
July 1 2004
End Date
May 1 2007
Last Update
June 1 2017
Active Locations (10)
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1
UCLA Medical Center-Dept of Pediatric Nephrology
Los Angeles, California, United States, 90095
2
Alfred Dupont Hospital for Children
Wilmington, Delaware, United States, 19899
3
Intermountains Orthopedics
Boise, Idaho, United States, 83702
4
Children's Hospital
Omaha, Nebraska, United States, 68198