A Double-Blind, Randomized, Placebo-Controlled, Multicenter 4-Week Study to Assess the Effect of Alendronate 70 mg and Vitamin D3 2800 IU Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
研究概览
简要总结
To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
详细描述
Placebo will be administered over a 4 week, single-blind run-in phase. Calcium, as citrate-malate, will be administered throughout the study at an individualized dose supplementing the patient's daily dietary calcium intake to a total of approximately 1200 mg. At the end of the stabilization period, baseline calcium absorption will be determined and patients will be randomized to receive either MK0217A, or matching placebo once weekly for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient is a postmenopausal osteoporotic female
- •The patient is willing to limit direct sunlight exposure during the course of the study
- •The patient must be ambulatory
- •The patient has serum 25-hydroxyvitamin D =25 ng/mL
排除标准
- •The patient is contraindicated to bisphosphonate therapy
- •The patient has a vitamin D deficiency
- •Patient will be excluded if their weight is above 85 kg
- •The patient has a history of prior osteoporotic fracture
- •The patient is currently or has received in the past treatment with effects on bone or calcium metabolism
- •The patient has malabsorption syndrome
- •The patient has active thyroid disease
- •The patient has metabolic bone disease
- •The patient had a myocardial infarction within 6 months of screening visit
- •The patient has impaired renal function
- •The patient is currently or has been a smoker in the last year
研究组 & 干预措施
1
MK0217A
干预措施: alendronate sodium (+) cholecalciferol (Drug)
结局指标
主要结局
To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
时间窗: 4 Weeks
次要结局
未报告次要终点