Bisphosphonate Treatment of Osteogenesis Imperfecta

May 31, 2017 updated by: Novartis Pharmaceuticals
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

158

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA - Division of Pediatric Nephrology
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Alfred I. DuPont Hospital for Children
    • Idaho
      • Boise, Idaho, United States, 83702
        • Intermountain Orthopedics
    • Illinois
      • Peoria, Illinois, United States, 61637
        • St. Jude Children's Research Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Children's Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Children's Hospital Medical Center
      • Columbus, Ohio, United States, 43205
        • Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

June 27, 2003

First Submitted That Met QC Criteria

June 27, 2003

First Posted (Estimate)

June 30, 2003

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446H2202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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