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

Completed · Phase 2

Conditions studied: Osteogenesis Imperfecta

In brief

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.

Key facts

Study ID

NCT00131118

Run by

Novartis Pharmaceuticals

People needed

127

Starts

2004-07-01

Expected to finish

2007-05-01

Last updated by the study team

2017-06-01

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• 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 — Omaha, Nebraska, 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
• Children's Hospital — Columbus, 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

Full record on ClinicalTrials.gov

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