Bisphosphonate Treatment of Osteogenesis Imperfecta

Novartis Pharmaceuticals158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

Osteogenesis Imperfecta

Interventions

Zoledronic AcidDRUG

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (10)

UCLA - Division of Pediatric Nephrology

Los Angeles, California, United States

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, United States

Intermountain Orthopedics

Boise, Idaho, United States

Outcomes

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

Data from ClinicalTrials.gov

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