A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
2016年8月31日 更新者：Hoffmann-La Roche
A Randomized Open-Label Study to Investigate the Impact of Bone Marker Feedback at 3 Months on Adherence to Monthly Oral Bonviva in Women With Post-Menopausal Osteoporosis Supported by a Patient Relationship Program
This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with post-menopausal osteoporosis supported by patient-relationship program (PRP).
Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP.
The anticipated time on study treatment is 3-12 months.
研究概览
研究类型
介入性
注册 (实际的)
716
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ekaterinburg、俄罗斯联邦、620102
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Irkutsk、俄罗斯联邦、664047
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Moscow、俄罗斯联邦、111123
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Moscow、俄罗斯联邦、129110
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Moscow、俄罗斯联邦、117997
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Moscow、俄罗斯联邦、127299
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Moscow、俄罗斯联邦、117036
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Moscow、俄罗斯联邦、125315
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Moscow、俄罗斯联邦、101990
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Moscow、俄罗斯联邦、115552
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Moscow、俄罗斯联邦、127473
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St Petersburg、俄罗斯联邦、199034
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St Petersburg、俄罗斯联邦、190068
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Voronezh、俄罗斯联邦、394066
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Yaroslavl、俄罗斯联邦、150003
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Budapest、匈牙利、1032
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Budapest、匈牙利、1027
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Budapest、匈牙利、1113
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Békéscsaba、匈牙利、5600
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Debrecen、匈牙利、4043
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Miskolc、匈牙利、3529
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Pecs、匈牙利、7624
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Szeged、匈牙利、6720
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Szekesfehervar、匈牙利、8000
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Szombathely、匈牙利、9700
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Liepaja、拉脱维亚、3400
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Riga、拉脱维亚、1038
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Riga、拉脱维亚、1004
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Riga、拉脱维亚、LV-1012
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Banska Bystrica、斯洛伐克、975 17
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Bratislava、斯洛伐克、826 06
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Lubochna、斯洛伐克、034 91
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Piestany、斯洛伐克、921 12
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Presov、斯洛伐克、080 01
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Ljubljana、斯洛文尼亚、1525
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Gliwice、波兰、44-100
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Krakow、波兰、30-510
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Lodz、波兰、90-549
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Poznan、波兰、60-355
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Warszawa、波兰、02-637
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Warszawa、波兰、00-909
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Warszawa、波兰、00-719
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Warszawa、波兰、02-507
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Wroclaw、波兰、50-367
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Bucharest、罗马尼亚、011172
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Bucharest、罗马尼亚、011364
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Bucharest、罗马尼亚、011461
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Bucharest、罗马尼亚、011863
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Cluj-napoca、罗马尼亚、400006
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Constanta、罗马尼亚、900709
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Craiova、罗马尼亚、300941
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Timisoara、罗马尼亚、300736
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- ambulatory, post-menopausal women with osteoporosis;
- eligible for bisphosphonate treatment;
- naïve to bisphosphonate therapy, or lapsed users (last bisphosphonate intake greater than or equal to [>=] 6 months ago).
Exclusion Criteria:
- inability to stand or sit upright for at least 60 minutes;
- inability to swallow a tablet whole;
- hypersensitivity to bisphosphonates;
- treatment with drugs, or presence of active disease, known to influence bone metabolism;
- history of upper gastrointestinal disease.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Bone Marker Feedback (BMF) Participants
Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months.
Participants, in this arm, will receive BMF at Month 3. BMF will be given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A "BMF-form" will be provided to the physicians to allow offering the bone marker result in an easy way.
Participants will be informed if their results are within or outside of the desired range.
In addition, participants will also supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
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Participants will receive ibandronate 150 mg QM orally for 6 months.
其他名称：
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有源比较器：No BMF Participants
Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months.
Participants will be supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
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Participants will receive ibandronate 150 mg QM orally for 6 months.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With Adherence to Treatment
大体时间：Up to 6 months
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Participants were considered adherent to treatment if they took at least 83 percent (%) of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month.
Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on case report form (CRF) and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6).
A drug dispensing log was maintained by the investigator.
Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.
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Up to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Composite Satisfaction High Scores
大体时间：At Month 6
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The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment.
It comprises four domains: convenience (questions 1 - 6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11 - 16).
Satisfaction with treatment was assessed using the OPSAT-Q composite satisfaction score, which was the average of the scores from the four domains of the OPSAT-Q converted to a 0 - 100-point scale.
Higher scores indicated greater treatment satisfaction.
A score of 80 or more was considered as high score.
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At Month 6
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Percentage of Participants With Osteoporosis Patient Perception Survey (OPPS) and Osteoporosis Medical Care Satisfaction Questionnaire (OMSQ) Composite Satisfaction High Score
大体时间：At Month 6
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OPPS: A standardized 6-item satisfaction questionnaire for osteoporosis medical care and treatment received during the study.
Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction.
The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.
OMSQ: A standardized 18-item satisfaction questionnaire for osteoporosis medical care, treatment received and blood test and their results during the study.
Individual item score was transformed and converted to a 0 to 100 scale where higher score indicated greater satisfaction.
The composite score was the average of individual item scores (transformed) and ranged from 0 to 100, where higher scores indicated greater satisfaction.
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At Month 6
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Percent Change From Baseline in CTX Based on Adherence to Ibandronate
大体时间：Baseline, Month 6
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Serum CTX, a biochemical marker of bone resorption, was assessed for all participants at baseline and at final visit (Month 6).
The sampling was done at the same time of the day each time to overcome the effect of circadian fluctuations.
Participants were considered adherent to treatment if they took at least 83% of their assigned medications (5 of the 6 monthly ibandronate tablets) within the -1 to +21 days of their osteoporosis treatment date each month.
Participant adherence was assessed by maintaining records of 'drug dispensed' and 'drug returned' on CRF and participant's self-report on Visit 2 (Month 3) and final study visit (Month 6).
A drug dispensing log was maintained by the investigator.
Participants were instructed at the baseline visit and Visit 2 to save and return unused or partially used medication packages on Visit 2 and final study visit, respectively.
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Baseline, Month 6
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年4月1日
初级完成 (实际的)
2008年1月1日
研究完成 (实际的)
2008年1月1日
研究注册日期
首次提交
2007年10月16日
首先提交符合 QC 标准的
2007年10月16日
首次发布 (估计)
2007年10月17日
研究记录更新
最后更新发布 (估计)
2016年10月24日
上次提交的符合 QC 标准的更新
2016年8月31日
最后验证
2016年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.