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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Osteogenesis Imperfecta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zoledronic Acid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No