A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this study is to investigate the influence of topiramate monotherapy on the bone and mineral metabolism markers, and bone density (the amount of mineral per square centimeter of bone ) in female participants with epilepsy (seizure disorder), before menopause (time in life when a woman stops having a menstrual period), as compared with healthy participants and comparative group received either carbamazepine or valproic acid monotherapy for at least last one year.

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Detailed Description

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This is a cross-sectional (observations or measurements made at a single point in time, usually at participant enrollment), multi-center (conducted in more than one center), and comparative study of topiramate monotherapy in female participants with epilepsy. Female participants must have received either topiramate, carbamazepine, or valproic acid monotherapy for more than one year for the treatment of epilepsy. Blood samples will be obtained from fasting participants to investigate the effect of study drug on the bone and mineral metabolism markers, and bone density compared to healthy participants and comparative group (carbamazepine and valproic acid monotherapy). Bone mineral density will be measured from the participants' lumbar spine or femur. A survey of food intake and physical activity for the participants will be performed using a standardized validated detailed questionnaire. The post-study visit (or follow up phone contact) will be performed for the occurrence of serious adverse events (SAE) for safety evaluation. Participants' safety will be monitored throughout the study.

Conditions

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Seizures Convulsions Epilepsy Osteopenia Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Topiramate

Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.

Topiramate

Intervention Type DRUG

This is an observational study. Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.

Carbamazepine

Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.

Carbamazepine

Intervention Type DRUG

This is an observational study. Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.

Valproic acid

Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.

Valproic acid

Intervention Type DRUG

This is an observational study. Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.

Normal Control

Healthy female participants will be observed in Normal control group.

Normal control

Intervention Type DRUG

This is an observational study. Healthy female participants will be observed in Normal control group.

Interventions

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Topiramate

This is an observational study. Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.

Intervention Type DRUG

Carbamazepine

This is an observational study. Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.

Intervention Type DRUG

Valproic acid

This is an observational study. Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.

Intervention Type DRUG

Normal control

This is an observational study. Healthy female participants will be observed in Normal control group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants who agree to participate in this study
* Female epileptic participants
* Participants who are receiving topiramate, carbamazepine or valproic acid monotherapy for more than one year
* Participants who are using proper contraceptive method (s) or have a negative pregnancy test result

Exclusion Criteria

* Participants with a motor function disorder
* Participants with a disease which affects their skeleton including primary hyperparathyroidism, Paget's disease, multiple myeloma, liver and kidney disorder, thyroid disease, malabsorption disorder, diabetes, and malignancies
* Participants who have taken within last one year, or are currently taking a drug which affects the bone and mineral metabolism such as vitamin D, calcium, anabolic steroids, bisphosphonates, calcitonin, glucocorticoids, and diuretics
* Voluntary or surgical postmenopausal participants
* Participants with amenorrhea for more than 6 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes