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临床试验/NCT01652690
NCT01652690已完成不适用

Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice

Amgen2 个研究点 分布在 2 个国家目标入组 600 人开始时间: 2012年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Amgen
入组人数
600
试验地点
2
主要终点
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection

时间窗: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)

Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection

时间窗: Month 24

Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.

Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection

时间窗: Month 6

Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.

Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection

时间窗: Month 12

Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.

Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection

时间窗: Month 18

Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.

Number of Denosumab Post-baseline Injections Received by Each Participant

时间窗: 24 months

Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office

时间窗: 24 months

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.

Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care

时间窗: 24 months

Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection

时间窗: Baseline (day 1)

Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.

Number of Participants Having Radiologic Bone Assessments

时间窗: Pre-baseline (before first denosumab injection) and during the study (post-baseline)

Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.

Number of Participants Having Osteoporosis Related Laboratory Examinations

时间窗: Pre-baseline (before first denosumab injection) and post-baseline

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.

Number of Participants Receiving All Prescriptions and Injections of Denosumab

时间窗: Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)

Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.

次要结局

  • Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab(24 months)
  • Number of Participants With Serious ADRs to Denosumab(24 months)

研究者

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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