EpilepsyNCT00204815
Bone Mineral Density in Pediatric Epilepsy
An observational study of Epilepsy, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Epilepsy
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric subjects with generalized or partial seizures
Who may be able to join
- diagnosis of generalized or partial seizures with or without generalization or a diagnosis of generalized seizures as defined in the International League Against Epilepsy
Who cannot join
- steroid use
- chronic disease other than epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: 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.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Raj Sheth, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204815
- Sponsor's protocol ID
- 2004-0015
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2005
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density in Pediatric Epilepsy: AED-Specific and Duration of Treatment-Specific Effects
- ClinicalTrials.gov ID
- NCT00204815
- Acronym / sponsor ID
- 2004-0015
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric subjects with generalized or partial seizures
Key inclusion criteria (1 listed)
- diagnosis of generalized or partial seizures with or without generalization or a diagnosis of generalized seizures as defined in the International League Against Epilepsy
Key exclusion criteria (2 listed)
- steroid use
- chronic disease other than epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raj Sheth, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.