Bisphosphonate Treatment of Osteogenesis Imperfecta

The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.

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Key information

Conditions

Osteogenesis Imperfecta Bone Diseases Bone Diseases, Developmental Bone Diseases, Metabolic Collagen Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Fractures, Bone Genetic Diseases, Inborn Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteochondrodysplasias Skin and Connective Tissue Diseases Wounds and Injuries

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA - Division of Pediatric Nephrology, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2003
Primary completion: 2007
Study completion: 2007
First posted: Jun 30, 2003
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