Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
2019年3月4日 更新者：Amgen
Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice
The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of these patients during the first 2 years of treatment.
In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.
研究概览
研究类型
观察性的
注册 (实际的)
600
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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Brno、捷克语、602 00
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Brno、捷克语、638 00
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Ceske Budejovice、捷克语、370 01
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Havlickuv Brod、捷克语、580 22
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Karlovy Vary、捷克语、367 17
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Kutna Hora、捷克语、284 01
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Ostrava、捷克语、702 00
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Ostrava-Trebovice、捷克语、722 00
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Plzen、捷克语、323 00
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Praha 11、捷克语、148 00
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Praha 2、捷克语、128 50
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Praha 4 - Nusle、捷克语、140 00
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Trutnov、捷克语、541 21
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Vsetin、捷克语、755 01
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Zlin、捷克语、760 01
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Zlin、捷克语
- Osteocentrum Zlin
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Banska Bystrica、斯洛伐克、974 01
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Bratislava、斯洛伐克、826 06
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Bratislava、斯洛伐克、833 05
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Humenne、斯洛伐克、066 01
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Kosice、斯洛伐克、040 01
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Kosice-Saca、斯洛伐克、040 15
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Lubochna、斯洛伐克、034 91
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Lucenec、斯洛伐克、984 01
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Martin、斯洛伐克、036 01
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Nitra、斯洛伐克、949 01
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Presov、斯洛伐克、080 01
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Trnava、斯洛伐克、917 75
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Zilina、斯洛伐克、010 01
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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
女性
取样方法
非概率样本
研究人群
The study was conducted at various study centers in the Czech Republic and Slovakia.
Postmenopausal women with osteoporosis who receive an injection of denosumab and meet the inclusion/exclusion criteria will be eligible to participate in the study.
描述
Inclusion Criteria
- Women with a clinical diagnosis of postmenopausal osteoporosis
- Decision has been made to treat with denosumab 60 mg once every 6 months
- Have received their first injection of denosumab within 8 weeks prior to enrolling in this study.
- Appropriate written informed consent has been obtained (as required per local country regulations)
Exclusion Criteria
- Participating in ongoing or have participated in previous denosumab clinical trials
- Participation in other clinical or device trials in the last 6 months
- Contra-indicated for treatment with Prolia® according to the approved applicable local product label.
- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent
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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Denosumab
Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.
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This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
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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Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
大体时间：24 months
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Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.
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24 months
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Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
大体时间：Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Number of Participants Receiving All Prescriptions and Injections of Denosumab
大体时间：Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.
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Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
大体时间：24 months
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24 months
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Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
大体时间：Baseline (day 1)
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.
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Baseline (day 1)
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Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
大体时间：Month 6
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.
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Month 6
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Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
大体时间：Month 12
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.
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Month 12
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Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
大体时间：Month 18
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.
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Month 18
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Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
大体时间：Month 24
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.
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Month 24
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Number of Denosumab Post-baseline Injections Received by Each Participant
大体时间：24 months
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24 months
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Number of Participants Having Radiologic Bone Assessments
大体时间：Pre-baseline (before first denosumab injection) and during the study (post-baseline)
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Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
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Pre-baseline (before first denosumab injection) and during the study (post-baseline)
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Number of Participants Having Osteoporosis Related Laboratory Examinations
大体时间：Pre-baseline (before first denosumab injection) and post-baseline
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Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study.
Participants may not have been given denosumab injection when they attended each visit.
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Pre-baseline (before first denosumab injection) and post-baseline
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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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Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
大体时间：24 months
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Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
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24 months
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Number of Participants With Serious ADRs to Denosumab
大体时间：24 months
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Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs).
A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.
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24 months
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2012年6月26日
初级完成 (实际的)
2015年5月15日
研究完成 (实际的)
2015年5月15日
研究注册日期
首次提交
2012年7月26日
首先提交符合 QC 标准的
2012年7月26日
首次发布 (估计)
2012年7月30日
研究记录更新
最后更新发布 (实际的)
2019年3月6日
上次提交的符合 QC 标准的更新
2019年3月4日
最后验证
2019年3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.