NCT00729651已完成4 期
A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 343
- 主要终点
- Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
研究概览
简要总结
To demonstrate the efficacy/safety of Fosamax Plus D
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
- •Patient has been diagnosed with osteoporosis
- •Patient has been postmenopausal for more than 6 months
- •Patient has no contraindication to taking oral bisphosphonates
- •Patient is eligible for dual energy x-ray absorptiometry in spine or hip
排除标准
- •Patients with esophageal dysfunction
- •Patients who can not sit or stand at least 30 minutes
- •Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
- •Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
- •Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months
研究组 & 干预措施
1
Experimental
Alendronate sodium/Cholecalciferol
干预措施: alendronate sodium (+) cholecalciferol (Drug)
结局指标
主要结局
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
时间窗: 16 weeks
次要结局
- Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment(Baseline and 16 weeks)
研究者
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