Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
2019年2月15日 更新者：Takeda
Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance -
The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.
研究概览
详细说明
This special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets 17.5 mg administered once daily (one tablet per dose) in patients with osseous Paget's disease in daily medical practice.
The usual dosage for adults is 17.5 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. For at least 30 minutes after administration, participants should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.
研究类型
观察性的
注册 (实际的)
315
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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Osaka、日本
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Tokyo、日本
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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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Osseous Paget's disease
描述
Inclusion Criteria:
- Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
Exclusion Criteria:
-
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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17.5 mg of sodium risedronate
17.5 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks.
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Sodium risedronate tablets
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 Who Had One or More Adverse Drug Reactions
大体时间：Up to 48 weeks
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Adverse drug reaction refers to adverse events related to administered drug.
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Up to 48 weeks
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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 Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
大体时间：Baseline and final assessment point (Up to 48 weeks)
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Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
大体时间：Baseline and final assessment point (Up to 48 weeks)
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Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported.
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
大体时间：Baseline and final assessment point (Up to 48 weeks)
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Investigators marked severity of pain with a 4-point scale ranging from "None" to "Very Severe" (None, Mild, Severe, Very Severe) at baseline and the final assessment point.
This scale was specified on the protocol of this observational study.
The reported data were number of participants stratified by comparison of pain severity between baseline and final assessment point described as "None (at baseline) to Severe (at final assessment point)".
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline
大体时间：Baseline and final assessment point (Up to 48 weeks)
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Investigator marked assessment of image findings of bone morphogenic abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened".
The reported data were the number of participants stratified by assessment of image findings at final assessment point.
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline
大体时间：Baseline and final assessment point (Up to 48 weeks)
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Investigator marked assessment of image findings of trabecular bone structural abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened".
The reported data were the number of participants stratified by assessment of image findings at final assessment point.
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline
大体时间：Baseline and final assessment point (Up to 48 weeks)
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Other Abnormalities refer to bone abnormal findings excluding bone morphogenic abnormalities and trabecular bone structural abnormalities (see Outcome Measure 5 and 6).
Investigator marked assessment of image findings of other abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened".
The reported data were the number of participants stratified by assessment of image findings at final assessment point.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point
大体时间：Baseline and final assessment point (Up to 48 weeks)
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Percentage of changes from baseline in urinary NTX level at final assessment point (up to 48 weeks) was reported.
Urinary NTX is one of bone metabolism markers.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point
大体时间：Baseline and final assessment point (Up to 48 weeks)
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Percentage of changes from baseline in urinary DPD level at final assessment point (up to 48 weeks) was reported.
Urinary DPD is one of bone metabolism markers.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point
大体时间：Baseline and final assessment point (Up to 48 weeks)
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Percentage of changes from baseline in serum BAP level at final assessment point (up to 48 weeks) was reported.
Serum BAP is one of bone metabolism markers.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
大体时间：Up to 48 weeks
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Treatment compliance of this outcome measure refers to the percentage of participants who correctly follow medication.
The reported data are percentage of participants in the classification including 4 specific degrees of treatment compliance; 90 % or more; 67 % or more and <90 %; 25 % or more and <67 %; less than 25 % or "unknown".
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Up to 48 weeks
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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。
赞助
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 (实际的)
2008年8月1日
初级完成 (实际的)
2017年10月24日
研究完成 (实际的)
2017年10月24日
研究注册日期
首次提交
2014年4月3日
首先提交符合 QC 标准的
2014年4月7日
首次发布 (估计)
2014年4月8日
研究记录更新
最后更新发布 (实际的)
2019年6月3日
上次提交的符合 QC 标准的更新
2019年2月15日
最后验证
2019年2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.