Clinical trial NCT01030094: A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy
Official title: A Cross-sectional, Comparative, Multi-center Study to Investigate the Effect of Topiramate Monotherapy on Markers of Bone Mineral Metabolism and Bone Mineral Density in Premenopausal Women With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures
Convulsions
Epilepsy
Osteopenia
Osteoporosis
Keywords: Topiramate
Carbamazepine
Valproic acid
Epilepsy
Bone mineral density
Monotherapy
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Female participants with epilepsy who are receiving topiramate, carbamazepine or valproic acid monotherapy for more than one year.

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Absolute Concentration of Calcium in Serum and Random Urine
timeFrame: 24 hours
measure: Absolute Concentration of 25-hydroxy Vitamin D, Osteocalcin, Carboxy-terminal Telopeptide of type 1 collagen (CTx) and Somatomedin-C (IGF-1) in Serum
timeFrame: 24 hours
measure: Absolute Concentration of 1-alpha 25-dihydroxyvitamin D-3, Parathyroid Hormone (PTH) in Serum
timeFrame: 24 hours
measure: Absolute Concentration of Bone-specific Alkaline Phosphatase (BSAP) in Serum
timeFrame: 24 hours
measure: Absolute Concentration of Bicarbonate in Serum
timeFrame: 24 hours
measure: Absolute Concentration of Calcium in Urine in 24 Hours
timeFrame: 24 hours
Secondary outcomes:
measure: Spine, Total hip and Femoral Neck Z-Score
timeFrame: 24 hours
measure: Percentage of Participants With Osteopenia and Osteoporosis Based on Spine T-score
timeFrame: 24 hours
measure: Percentage of Participants With Osteopenia and Osteoporosis Based on Spine Z-score
timeFrame: 24 hours
measure: Absolute Concentration of Phosphorus and Creatinine in Random Urine
timeFrame: 24 hours
measure: Absolute concentration of Sodium in Random Urine
timeFrame: 24 hours
measure: Absolute Concentration of Phosphorus and Creatinine in 24 Hour Urine
timeFrame: 24 hours
measure: Absolute concentration of Sodium in 24 Hour Urine
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: