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Bone Mineral Density in Pediatric Epilepsy

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204815
First received: September 12, 2005
Last updated: June 11, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bone Mineral Density in Pediatric Epilepsy: AED-Specific and Duration of Treatment-Specific Effects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Enrollment: 98
Study Start Date: January 2005
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric subjects with generalized or partial seizures

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204815

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
GlaxoSmithKline
Investigators
Principal Investigator: Raj Sheth, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Raj Sheth, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00204815     History of Changes
Other Study ID Numbers: 2004-0015
Study First Received: September 12, 2005
Last Updated: June 11, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013