Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Women With Epilepsy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This clinical study will investigate the influence of topiramate monotherapy on the bone and mineral metabolism markers and bone density of female epilepsy patients before menopause, compared to healthy patients and comparative group (carbamazepine and valproic acid monotherapy which are used most often).
| Condition | Intervention | Phase |
|---|---|---|
|
Seizures Convulsions Epilepsy Osteopenia Osteoporosis |
Drug: Topiramate; Carbamazepine; Valproic Acid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- To compare the difference in bone and mineral metabolism markers between Topiramate, Carbamazepine and Valproic acid monotherapy groups [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To compare and analyze the following items of Topiramate, Carbamazepine, and Valproic acid monotherapy groups: Bone density, Osteopenia and osteoporosis, several markers in 24h urine such as clacium, phosphorus, sodium and creatinine [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]
| Enrollment: | 142 |
| Study Start Date: | February 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Epilepsy patients taking antiepileptics have a high risk of osteopenia (a condition where bone mineral density is lower than normal) and osteoporosis (a disease of bone that leads to an increased risk of fracture) due to abnormal bone metabolism. One of the most important complications of abnormal bone health is fracture, of which the risk increases in epilepsy patients. Bone fractures may result from seizures, but taking antiepileptics (a diverse group of pharmaceuticals used in the treatment of epileptic seizures) is an independent factor of fracture. Fracture is associated with hospitalization, loss of independence, and death. Consequently, it is important to recognize patients with the risk of fracture and medications which may negatively influence bone health. It is not exactly known which mechanism of antiepileptics may have a negative influence on bone density. This study will investigate the influence of topiramate monotherapy on the bone and mineral metabolism markers and bone density of female epilepsy patients before menopause, compared to healthy patients and comparative group (carbamazepine and valproic acid monotherapy which are thought most generally used). This is a cross-sectional, comparative, multi-center study. The patients are women who have received topiramate, carbamazepine, or valproic acid monotherapy for more than one year for the treatment of epilepsy. For the duration of treatment, the patients must have received a monotherapy for at least one year. In this clinical study, blood samples from fasting patients will be obtained and tested for a bone mineral density-related substance. Various other laboratory tests will be performed on blood and urine samples. Bone mineral density will be measured from the patients' lumbar spine or femur. A survey of food intake and physical activity for the patients from each center 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. Topiramate, carbamazepine, or valproic acid monotherapy for more than one year as per product label
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who agree to participate in this study
- Patients who are receiving topiramate, carbamazepine or valproic acid monotherapy for more than one year
- Patients who are using proper contraceptive method(s) or have a negative pregnancy test result
Exclusion Criteria:
- Patients with a motor function disorder
- Patients 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
- Patients 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
- Patients who were pregnant within last one year or are pregnant
- Voluntary or surgical postmenopausal patients (for those who have undergone a hysterectomy, the E2 (estradiol:the predominant sex hormone present in females:) and FSH (follicle stimulating hormone:It is synthesized and secreted by gonadotropes of the anterior pituitary gland) levels confirmed to be normal)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT01030094 History of Changes |
| Other Study ID Numbers: | CR015856, TOP-KOR-31 |
| Study First Received: | December 10, 2009 |
| Last Updated: | January 28, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Topiramate Epilepsy Bone mineral density Monotherapy |
Additional relevant MeSH terms:
|
Seizures Epilepsy Bone Diseases, Metabolic Osteoporosis Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Bone Diseases Musculoskeletal Diseases Topiramate Valproic Acid Carbamazepine Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on May 22, 2013