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