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

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Janssen

Status

Completed

Conditions

Osteoporosis
Osteopenia
Seizures
Convulsions
Epilepsy

Treatments

Drug: Topiramate
Drug: Valproic acid
Drug: Normal control
Drug: Carbamazepine

Study type

Observational

Funder types

Industry

Identifiers

NCT01030094
TOP-KOR-31
CR015856

Details and patient eligibility

About

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.

Full description

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.

Enrollment

140 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

140 participants in 4 patient groups

Topiramate
Description:
Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.
Treatment:
Drug: Topiramate
Carbamazepine
Description:
Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.
Treatment:
Drug: Carbamazepine
Valproic acid
Description:
Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.
Treatment:
Drug: Valproic acid
Normal Control
Description:
Healthy female participants will be observed in Normal control group.
Treatment:
Drug: Normal control

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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