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

NCT01030094 | Completed

• 2 other identifiers: CR015856TOP-KOR-31
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Seizures; Convulsions; Epilepsy; Osteopenia; Osteoporosis

Keywords

Topiramate; Carbamazepine; Valproic acid; Epilepsy; Bone mineral density; Monotherapy

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• Absolute Concentration of Calcium in Urine in 24 Hours

  Absolute concentration of calcium in urine will be examined by urine test.

  24 hours

Secondary Outcomes (7)

• Spine, Total hip and Femoral Neck Z-Score

  24 hours

• Percentage of Participants With Osteopenia and Osteoporosis Based on Spine T-score

  24 hours

• Percentage of Participants With Osteopenia and Osteoporosis Based on Spine Z-score

  24 hours

• Absolute Concentration of Phosphorus and Creatinine in Random Urine

  24 hours

• Absolute concentration of Sodium in Random Urine

  24 hours

Study Arms (4)

Topiramate

Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.

Drug: Topiramate

Carbamazepine

Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.

Drug: Carbamazepine

Valproic acid

Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.

Drug: Valproic acid

Normal Control

Healthy female participants will be observed in Normal control group.

Drug: Normal control

Interventions

Topiramate DRUG

This is an observational study. Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.

Topiramate

Carbamazepine DRUG

This is an observational study. Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.

Carbamazepine

Valproic acid DRUG

This is an observational study. Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.

Valproic acid

Normal control DRUG

This is an observational study. Healthy female participants will be observed in Normal control group.

Normal Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female participants with epilepsy who are receiving topiramate, carbamazepine or valproic acid monotherapy for more than one year.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Seizures; Epilepsy; Bone Diseases, Metabolic; Osteoporosis

Interventions

Topiramate; Carbamazepine; Valproic Acid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: February 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 26, 2013

Record last verified: 2013-06