NCT02598453已完成4 期
An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate
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
- 545
- 主要终点
- Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate
研究概览
简要总结
The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with postmenopausal osteoporosis or osteopenia
- •Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)
排除标准
- •Inability to stand or sit upright for 60 minutes
- •Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva
- •Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy
- •Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy
研究组 & 干预措施
Ibandronate Oral
Experimental
Participants will receive ibandronate 150 milligrams (mg) tablet once monthly
干预措施: Ibandronate (Drug)
Ibandronate IV
Experimental
Participants will receive ibandronate 3 mg IV once every 3 months
干预措施: Ibandronate (Drug)
结局指标
主要结局
Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate
时间窗: 12 months
次要结局
- Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants(12 months)
- Percentage of participants with GI events based on severity(Up to 10 months)
- Percentage of participants who experienced a change in frequency and number of GI events(Up to 10 months)
研究者
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