36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets
2019年7月18日 更新者：Takeda
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Benet 75 mg Tablets
The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.
研究概览
详细说明
This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets in osteoporosis patients in daily medical practice.
The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.
研究类型
观察性的
注册 (实际的)
579
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
50年 及以上 (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
非概率样本
研究人群
Osteoporosis
描述
Inclusion Criteria:
Osteoporosis patients who meet all the following criteria:
- Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets)
- Male and postmenopausal female patients aged 50 years or older
- Ambulatory outpatients
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 |
|---|---|
|
Sodium Risedronate 75 mg
75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.
Participants receive sodium risedronate 75 mg as part of routine medical care.
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Sodium risedronate tablets
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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 |
|---|---|---|
|
Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
大体时间：From baseline up to Month 36
|
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
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From baseline up to Month 36
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative Percentage of Participants With Non-Vertebral Body Fractures
大体时间：From baseline up to Month 36
|
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
|
From baseline up to Month 36
|
|
Cumulative Percentage of Participants With Femur Fractures
大体时间：From baseline up to Month 36
|
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
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From baseline up to Month 36
|
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Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
|
BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
|
BMD was measured by dual-energy X-ray absorptiometry.
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Baseline and final assessment (up to Month 36)
|
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Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
|
BMD was measured by dual-energy X-ray absorptiometry.
|
Baseline and final assessment (up to Month 36)
|
|
Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
|
BMD was measured by dual-energy X-ray absorptiometry.
|
Baseline and final assessment (up to Month 36)
|
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Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
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|
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Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
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Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
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|
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Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
|
Baseline and final assessment (up to Month 36)
|
|
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Change From Baseline in Height at Final Assessment (up to Month 36)
大体时间：Baseline and final assessment (up to Month 36)
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Baseline and final assessment (up to Month 36)
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|
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Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
大体时间：Final assessment (up to Month 36)
|
Final assessment (up to Month 36)
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Number of Participants Who Had One or More Adverse Drug Reactions
大体时间：Up to Month 36
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Adverse drug reaction refers to adverse events related to the administered drug.
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Up to Month 36
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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)
2013年5月13日
初级完成 (实际的)
2018年4月30日
研究完成 (实际的)
2018年4月30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3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7月30日
上次提交的符合 QC 标准的更新
2019年7月18日
最后验证
2019年7月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 178-002
- JapicCTI-142479 (注册表标识符：JapicCTI)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com
for details).
To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias.
Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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