A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-menopausal Osteoporosis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 585
- 主要终点
- Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
研究概览
简要总结
This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. 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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ambulatory post-menopausal women with osteoporosis;
- •55-85 years of age;
- •eligible for bisphosphonate treatment;
- •naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago).
排除标准
- •inability to stand or sit in an upright position for at least 60 minutes;
- •inability to swallow a tablet whole;
- •hypersensitivity to bisphosphonates;
- •administration of any drug, or presence of active disease, known to influence bone metabolism;
- •uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
- •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)
结局指标
主要结局
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group
时间窗: 6 months
次要结局
- Patient satisfaction by OPSAT-Q and OPPS.(6 months)
- Tolerability; SAEs.(Throughout study)