Bone Mineral Density in Pediatric Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204815
• Other study ID #: 2004-0015
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 1, 2015
• Start date: January 2005
• Est. completion date: October 2007

Study information

• Verified date: June 2008
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	GlaxoSmithKline

Country where clinical trial is conducted

United States,