Bone Mineral Density in Pediatric Epilepsy

October 1, 2015 updated by: University of Wisconsin, Madison

Bone Mineral Density in Pediatric Epilepsy: AED-Specific and Duration of Treatment-Specific Effects

What are the effects of the currently used AEDs on bone mineralization in children and adolescents between the ages of 8 to 18? This is a pilot observational study using DEXA scans to measure bone mineral density in 100 patients The primary objective is to collect preliminary data on bone mineral density, body weight, dietary calcium intake, and activity level.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

98

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
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

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

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric subjects with generalized or partial seizures

Description

Inclusion Criteria:

  • diagnosis of generalized or partial seizures with or without generalization or a diagnosis of generalized seizures as defined in the International League Against Epilepsy

Exclusion Criteria:

  • steroid use
  • chronic disease other than epilepsy

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

Collaborators and Investigators

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

Sponsor

University of Wisconsin, Madison

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Raj Sheth, MD, University of Wisconsin, Madison

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

January 1, 2005

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-0015

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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