A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seizures; Convulsions; Epilepsy; Osteopenia; Osteoporosis
Intervention: Topiramate (Drug); Carbamazepine (Drug); Valproic acid (Drug); Normal control (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s): Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd., Korea
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.
Clinical Details
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 design: Observational Model: Cohort, Time Perspective: Cross-Sectional
Primary outcome: Absolute Concentration of Calcium in Serum and Random UrineAbsolute Concentration of 25-hydroxy Vitamin D, Osteocalcin, Carboxy-terminal Telopeptide of type 1 collagen (CTx) and Somatomedin-C (IGF-1) in Serum Absolute Concentration of 1-alpha 25-dihydroxyvitamin D-3, Parathyroid Hormone (PTH) in Serum Absolute Concentration of Bone-specific Alkaline Phosphatase (BSAP) in Serum Absolute Concentration of Bicarbonate in Serum Absolute Concentration of Calcium in Urine in 24 Hours
Secondary outcome: Spine, Total hip and Femoral Neck Z-ScorePercentage of Participants With Osteopenia and Osteoporosis Based on Spine T-score Percentage of Participants With Osteopenia and Osteoporosis Based on Spine Z-score Absolute Concentration of Phosphorus and Creatinine in Random Urine Absolute concentration of Sodium in Random Urine Absolute Concentration of Phosphorus and Creatinine in 24 Hour Urine Absolute concentration of Sodium in 24 Hour Urine
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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: February 2007
Last updated: June 25, 2013
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