NCT00097812已完成3 期
A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 25
- 主要终点
- To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations
研究概览
简要总结
The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.
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
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women between 45 and 79 years of age
- •Must be osteopenic/osteoporotic
- •Treatment with oral bisphosphonate for at least 1 year
排除标准
- •Any woman of child bearing potential
- •Treatment with other bone active agents
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations
次要结局
- To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations
- To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients
- To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire
研究者
研究点 (25)
Loading locations...
相似试验
Unknown
不适用
Impact of Biological Factors on Dental ImplantDental ImplantNCT06037070Al-Mustansiriyah University10
Unknown
不适用
Minimally Invasive Ridge Splitting Versus the Conventional Open Flap TechniqueAlveolar Bone LossNCT06329362The Royal College of Surgeons of Edinburgh16
Unknown
不适用
Study to Measure the Effect of Part Time Versus Full Time Orthodontic Appliance WearClass II Division 1 MalocclusionNCT02190630Queen Mary University of London62
已完成
不适用
Dental Care and Initiation of Anti-osteoporotic TherapyDental ConditionOsteoporosisNCT05719818Centre Hospitalier Universitaire de Nice338
已完成
不适用
Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed TomographyClass II MalocclusionNCT06308640Tanta University20