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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 Urine

Absolute 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-Score

Percentage 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

Page last updated: August 23, 2015

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