'Open, Prospective, Multi-center, Two-part Study of Patient Preference With Monthly Ibandronate Therapy in Women With Postmenopausal Osteoporosis Switched From Once-daily or Once Weekly Alendronate or Risendronate - BONCURE (BONviva for Current Bisphosphonate Users - Regional European Trial)'
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 677
- 主要终点
- Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ)
研究概览
简要总结
This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. 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
- Na
- 干预模型
- Single Group
- 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
- •post-menopausal women;
- •>=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.
排除标准
- •inability to stand or sit in an upright position for at least 60 minutes;
- •hypersensitivity to bisphosphonates;
- •treatment with other drugs affecting bone metabolism;
- •abnormalities of the oesophagus, which delay oesophageal emptying.
研究组 & 干预措施
Ibandronate
Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
干预措施: Ibandronate (Drug)
结局指标
主要结局
Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ)
时间窗: Visit 0 (less than or equal to [<=] Day -30)
The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: 1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule. 2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication. 3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication.
Percentage of Participants Who Reported Preference for Monthly Ibandronate
时间窗: Visit 0 (<= Day -30)
Percentage of participants who reported preference for monthly ibandronate were reported.
Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group
时间窗: Month 6
Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.
次要结局
- Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ(Visit 0 (<= Day -30))
- Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B(Visit 0 (<= Day -30))
- Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B(Month 6)
- Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B(Up to Month 6)
- Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B(Baseline to Month 6)
- Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B(Month 6)
- Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B(Baseline, Month 6)