NCT00148915已完成4 期
A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150 mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year
研究概览
简要总结
The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive ibandronate matched placebo tablet orally once monthly for one year.
干预措施: Placebo (Drug)
Ibandronate
Experimental
Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year.
干预措施: ibandronate (Drug)
结局指标
主要结局
Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year
时间窗: Year 1
次要结局
- Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year(Year 1)
- Hip geometry assessed by cross-sectional dimensions of hip using DXA(Year 1)
- Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans(Year 1)
- Hip geometry assessed by cross-sectional dimensions of hip using vQCT(Year 1)
- Finite element composition of hip and spine to estimate hip and spine strength(Year 1)
- Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality(Year 1)
- Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)(Months 3, 6, 9, and 12)
- Change from baseline for bone-specific alkaline phosphatase (Bone ALP)(Months 3, 6, 9, and 12)
研究者
研究点 (1)
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