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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Absolute Concentration of Calcium in Serum and Random Urine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Topiramate
Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.
干预措施: Topiramate (Drug)
Carbamazepine
Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.
干预措施: Carbamazepine (Drug)
Valproic acid
Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.
干预措施: Valproic acid (Drug)
Normal Control
Healthy female participants will be observed in Normal control group.
干预措施: Normal control (Drug)
结局指标
主要结局
Absolute Concentration of Calcium in Serum and Random Urine
时间窗: 24 hours
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.
Absolute Concentration of 25-hydroxy Vitamin D, Osteocalcin, Carboxy-terminal Telopeptide of type 1 collagen (CTx) and Somatomedin-C (IGF-1) in Serum
时间窗: 24 hours
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.
Absolute Concentration of 1-alpha 25-dihydroxyvitamin D-3, Parathyroid Hormone (PTH) in Serum
时间窗: 24 hours
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.
Absolute Concentration of Bone-specific Alkaline Phosphatase (BSAP) in Serum
时间窗: 24 hours
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.
Absolute Concentration of Bicarbonate in Serum
时间窗: 24 hours
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.
Absolute Concentration of Calcium in Urine in 24 Hours
时间窗: 24 hours
Absolute concentration of calcium in urine will be examined by urine test.
次要结局
- 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)
- Absolute Concentration of Phosphorus and Creatinine in 24 Hour Urine(24 hours)
- Absolute concentration of Sodium in 24 Hour Urine(24 hours)