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

Novartis Pharmaceuticals127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

127

Conditions

Osteogenesis Imperfecta

Interventions

Zoledronic AcidDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (10)

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

Outcomes

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.

Data from ClinicalTrials.gov

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