NCT00745485已完成4 期
A Phase IV Study of the Safety and Feasibility of Rooms-based Infusion of Zoledronic Acid for Women With Post-menopausal Osteoporosis
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
- 186
- 试验地点
- 1
- 主要终点
- Bone Mineral Density
研究概览
简要总结
- The study will assess the safety and tolerability of a single-infusion of zoledronic acid 5 mg administered in a private medical practice setting by a nurse provided by a nationwide infusion service. Safety data will largely be monitored by investigating changes in the patients' well-being during the study.
- The study will pilot and test a Patient Registry and Infusion Service process, which will allow zoledronic acid to be administered to trial patients in the investigators' private rooms by a team of roving nurses.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female after menopause with osteoporosis either: 70 years of age or older with a bone mineral density T-score of -3.0 or less OR with a fracture due to minimal trauma.
排除标准
- •Intravenous bisphosphonate within the past 12 months
- •Abnormal levels of protein in the urine via dipstick at screening if not caused by bacterial infection
- •Abnormal liver function tests greater than twice normal
- •Evidence of high bone turnover
- •Abnormal calcium blood levels
- •Low Vitamin D levels
- •Poor renal function
- •Abnormal parathyroid function or uncontrolled, abnormal thyroid function
- •History of eye inflammation
- •History of diabetes leading to kidney or eye problems
- •A history of cancer except some non-invasive cancers of skin, colon, breast and cervix
- •Patients with severe dental problems or current dental infections Or requiring dental surgery
- •Known sensitivity to zoledronic acid or bisphosphonates
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Zoldronic
Experimental
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Bone Mineral Density
时间窗: at baseline and month 12
Bone turnover
时间窗: at baseline and month 12
次要结局
未报告次要终点
研究者
研究点 (1)
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