Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
- Conditions
- Osteogenesis Imperfecta
- Registration Number
- NCT00131118
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- Have completed the core CZOL446H2202 study
- Males or females between 1-17 years of age
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
Trial Locations
- Locations (9)
UCLA Medical Center-Dept of Pediatric Nephrology
🇺🇸Los Angeles, California, United States
Alfred Dupont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Intermountains Orthopedics
🇺🇸Boise, Idaho, United States
Children's Hospital
🇺🇸Columbus, Ohio, United States
For information regarding facilities, please contact the Central Contact
🇺🇸Multiple Locations, New Jersey, United States
Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
UCLA Medical Center-Dept of Pediatric Nephrology🇺🇸Los Angeles, California, United States