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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Carbamazepine; Topiramate; Valproic Acid

Criteria

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