跳至主要内容
临床试验/NCT02948881
NCT02948881已完成4 期

A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis

GlaxoSmithKline16 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年8月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
16
主要终点
Bone quality and strength at the hip by characterizing changes in trabecular and cortical bone quality using Volumetric Quantitative Computed Tomography (vQCT) and novel imaging analysis methods, including a subset of bone biopsies for one year.

研究概览

简要总结

The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip 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

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Bone quality and strength at the hip by characterizing changes in trabecular and cortical bone quality using Volumetric Quantitative Computed Tomography (vQCT) and novel imaging analysis methods, including a subset of bone biopsies for one year.

时间窗: 1 Year

次要结局

  • Relationship between biomarkers and changes in bone quality for one year.(1 Year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (16)

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