Prospective Observational Study to Describe Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France and Its Use 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
- 777
- 试验地点
- 1
- 主要终点
- patient occurence of persistence (persistence is defined in the outcome description) at 12 months
研究概览
简要总结
The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France
详细描述
This is a multicenter, observational and non-interventional study in PMO patients who receive Prolia® (60 mg subcutaneous [SC]) in France. Patients in the study will be enrolled in 2 waves, each targeting specific aspects of the overall study objectives. The first wave will enroll approximately 500 patients who will be followed for approximately 30 months from the first injection. Patients enrolled in this wave will provide descriptive data on persistence to Prolia® as well as a description of the characteristics of patients being prescribed Prolia®, information regarding Prolia® prescription and administration, procedures pertaining to Prolia® and safety.
The second wave will enroll approximately 250 patients and will only provide a cross-sectional description of the characteristics of patients being prescribed Prolia.
Around 2000 specialists in rheumatology and 9000 general practitioners will be randomly selected from a list of rheumatologists whether in hospital or private practice nationwide and a list of general practitioners managing patients with osteoporosis.
In all, 300 physicians initially interested to participate are expected, from which about 180 physicians will be qualified to participate. One-hundred and ten physicians will be initiated.
There are no procedures or changes to the routine clinical management of patients participating in the study. Baseline characteristics will be described for patients enrolling in both waves 1 and 2. Patients enrolling in wave 1 will be followed for approximately 30 months from the date of first injection in the study. It is anticipated that patients will return to the site. Clinical information obtained for routine clinical practice will be recorded where available, including Prolia administration, previous and current therapies, medical history (including fracture), ADRs, SADRs and co-morbidities.The study is descriptive in nature, and no formal hypothesis will be tested. In general, data summaries will be presented by wave and by subgroups of interest.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •post menopausal osteoporosis women in whom a decision has been made to treat with Prolia in the last 4 weeks
- •received their first prescription of Prolia in the last 4 weeks
- •patient has provided informed consent before enrolling in the study
排除标准
- •patients participating in ongoing or previous Denosumab clinical trials
研究组 & 干预措施
wave 1
postmenopausal women with osteoporosis treated with Prolia
干预措施: AMG 162 - Prolia (Drug)
wave 2
postmenopausal women with osteoporosis treated with Prolia
干预措施: AMG 162 - Prolia (Drug)
结局指标
主要结局
patient occurence of persistence (persistence is defined in the outcome description) at 12 months
时间窗: 12 months
To evaluate the persistence with Prolia at 12 months in post menopausal women with osteoporosis (PMO) in France. To evaluate the persistence with Prolia at 24 months in PMO women in France. Patients will be defined as persistent with Prolia at 12 months if the patient receives at least 2 injections and the second injection at 6 months is no later than 6 months + 8 weeks (or 239 days) from the baseline injection
次要结局
- describe the use of Prolia in routine clinical practice during approximately 30 months from the first injection(30 months from first injection)
- Occurrence of patient reported osteoporosis related vertebral and non vertebral fractures reported during the study(30 months or early termination)
- patient occurence of Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs) as collected in routine clinical practice(30 months or early termination)
- patient occurence of persistence (persistence is defined in the outcome description) at 24 months and time to non-persistence at 24 months(24 months)