Bisphosphonate Treatment of Osteogenesis Imperfecta

NCT ID: NCT00063479

Last Updated: 2017-06-01

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

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2007-05-31

Brief Summary

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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.

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

* 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
Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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UCLA - Division of Pediatric Nephrology

Los Angeles, California, United States

Site Status

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, United States

Site Status

Intermountain Orthopedics

Boise, Idaho, United States

Site Status

St. Jude Children's Research Hospital

Peoria, Illinois, United States

Site Status

Children's Hospital

Omaha, Nebraska, United States

Site Status

Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Children's Hospital

Columbus, Ohio, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Texas Children's Hosptial

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CZOL446H2202

Identifier Type: -

Identifier Source: org_study_id

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