A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 801
- 主要终点
- Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
研究概览
简要总结
This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients, >=60 years of age;
- •>=5 years postmenopausal;
- •confirmed osteoporosis, at increased risk for renal disease.
排除标准
- •inability to stand or sit upright for 30 minutes;
- •hypersensitivity to bisphosphonates;
- •malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years;
- •previous administration of an i.v. bisphosphonate;
- •oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study;
- •history of major upper gastrointestinal disease.
研究组 & 干预措施
1
干预措施: ibandronate [Bonviva/Boniva] (Drug)
2
干预措施: ibandronate [Bonviva/Boniva] (Drug)
3
干预措施: Alendronate (Drug)
结局指标
主要结局
Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
时间窗: Baseline and 9 months
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.
次要结局
- Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)(Baseline and 9 months)
- Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)(Baseline and 9 months)
- Relative Change From Baseline in Actual GFR (Using CG Formula)(Baseline and 9 months)
- Absolute Change From Baseline in Mean Serum Creatinine.(Baseline and 9 months)
- Relative Change From Baseline in Mean Serum Creatinine.(Baseline and 9 months)
- Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.(Baseline and 9 months)
- Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.(Baseline and 9 months)