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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030094
• Other study ID #: CR015856
• Secondary ID: TOP-KOR-31
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2009
• Last updated: June 25, 2013
• Start date: February 2007
• Est. completion date: April 2009

Study information

• Verified date: June 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Convulsions
• Epilepsy
• Osteopenia
• Osteoporosis
• Seizures

Intervention

Drug:
• Topiramate
This is an observational study. Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.
• Carbamazepine
This is an observational study. Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.
• Valproic acid
This is an observational study. Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.
• Normal control
This is an observational study. Healthy female participants will be observed in Normal control group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Concentration of Calcium in Serum and Random Urine	Bone and mineral metabolic marker represents the structure, cyclical metabolism, and hormone regulation of bone. Urinary calcium is one of the indicators of bone resorption (bone loss due to osteoclastic activity). Absolute concentration of calcium in serum and random urine will be assessed.	24 hours	No
Primary	Absolute Concentration of 25-hydroxy Vitamin D, Osteocalcin, Carboxy-terminal Telopeptide of type 1 collagen (CTx) and Somatomedin-C (IGF-1) in Serum	Osteocalcin is a vitamin K-dependent calcium-binding protein synthesized by osteoblasts and found primarily in bones. Serum osteocalcin measurements provide a noninvasive specific marker of bone metabolism. CTx is marker for bone resorption (bone loss due to osteoclastic activity). IGF-1 has growth-regulating, insulin-like, and mitogenic activities. Absolute concentration of 25-hydroxy vitamin D, osteocalcin, carboxy-terminal telopeptide of type 1 collagen (CTx) and somatomedin-C (IGF-1) in serum will be assessed.	24 hours	No
Primary	Absolute Concentration of 1-alpha 25-dihydroxyvitamin D-3, Parathyroid Hormone (PTH) in Serum	Bone and mineral metabolic marker represents the structure, cyclical metabolism, and hormone regulation of bone. 1-alpha 25-dihydroxyvitamin D-3 (vitamin D-3) and Parathyroid hormone (PTH) were assessed. The PTH maintains intracellular calcium levels in the body.	24 hours	No
Primary	Absolute Concentration of Bone-specific Alkaline Phosphatase (BSAP) in Serum	Bone and mineral metabolic marker represents the structure, cyclical metabolism, and hormone regulation of bone. Bone-specific alkaline phosphatase (BSAP) reflects formation of organic matrix in bone. Absolute concentration of BSAP in Serum will be assessed.	24 hours	No
Primary	Absolute Concentration of Bicarbonate in Serum	Bicarbonate levels in the blood are an index of the alkali reserve or buffering capacity. Difference in Bicarbonate level between topiramate, carbamazepine and valproic acid monotherapy groups will be assessed.	24 hours	No
Primary	Absolute Concentration of Calcium in Urine in 24 Hours	Absolute concentration of calcium in urine will be examined by urine test.	24 hours	No
Secondary	Spine, Total hip and Femoral Neck Z-Score	Z-score is number of standard deviations a participant's bone mineral density (BMD) differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values". Z-score will be evaluated for spine, hip and femoral neck.	24 hours	No
Secondary	Percentage of Participants With Osteopenia and Osteoporosis Based on Spine T-score	Osteoporosis means reduction of bone mass without alteration in the composition of bone, leading to fractures. Osteopenia is a metabolic bone disease. The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD. Percentage of participants with osteopenia and osteoporosis based on spine T-score will be assessed.	24 hours	No
Secondary	Percentage of Participants With Osteopenia and Osteoporosis Based on Spine Z-score	Osteoporosis means reduction of bone mass without alteration in the composition of bone, leading to fractures. Osteopenia is a metabolic bone disease. The Z-score is number of standard deviations a participant's bone mineral density (BMD) differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values". Z-score will be evaluated for spine, hip and femoral neck. Percentage of participants with osteopenia and osteoporosis based on spine Z-score will be assessed.	24 hours	No
Secondary	Absolute Concentration of Phosphorus and Creatinine in Random Urine	Absolute concentration of phosphorus and creatinine in urine will be examined by urine test.	24 hours	No
Secondary	Absolute concentration of Sodium in Random Urine	Absolute concentration of sodium in urine will be examined by urine test.	24 hours	No
Secondary	Absolute Concentration of Phosphorus and Creatinine in 24 Hour Urine	Absolute concentration of phosphorus and creatinine in 24 hour urine will be examined by urine test.	24 hours	No
Secondary	Absolute concentration of Sodium in 24 Hour Urine	Absolute concentration of sodium in 24 hour urine will be examined by urine test.	24 hours	No