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

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.

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Key information

Conditions

Osteogenesis Imperfecta Bone Diseases Bone Diseases, Developmental Collagen Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias Skin and Connective Tissue Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA Medical Center-Dept of Pediatric Nephrology, Los Angeles, California, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: Aug 17, 2005
Registry last updated: Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed