A Retrospective, Observational Cohort Study Evaluating the Effectiveness and Cardiovascular Safety of Abaloparatide in Postmenopausal Women New to Anabolic Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22,054
- 试验地点
- 1
- 主要终点
- Number of Participants With a Nonvertebral Fracture
研究概览
简要总结
The purpose of the study is to evaluate the real-world effectiveness and cardiovascular safety of ABL compared with TPTD during the 18-month period after treatment initiation in propensity score (PS)-matched cohorts
详细描述
This is a retrospective observational cohort study using healthcare administrative claims data from the USA.
This study will use anonymized patient claims data from PRA's Symphony Health Patient Source Integrated Dataverse (IDV) database including the enhanced hospital data. Data are routinely collected in healthcare encounters from all available healthcare sites (inpatient hospital, outpatient hospital, physician office, pharmacy, etc.) for all types of provided services including specialty, preventive care, and office-based treatments.
The patients for inclusion in the study analyses will be identified based on the prescribed anabolic therapy filled (ABL or TPTD). The identification period (May 1, 2017 to June 30, 2019) was chosen to coincide with the date of the FDA approval of ABL in the USA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are 50 years or older
- •≥1 prescription fill for ABL or TPTD during the identification period
- •≥ 1 claim for medical or hospital visit and a pharmacy claim in the 12 months before the index date
排除标准
- •Paget's disease
- •Malignancy, except for nonmelanoma skin cancers, carcinoma in-situ of the cervix, ductal carcinoma in-situ of breast
- •Indicators of high disease burden and high risk of death
- •With prior index anabolic treatment
- •Switch to a different anabolic treatment after index date
研究组 & 干预措施
Patients Treated with Abaloparatide
Patients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period.
干预措施: Abaloparatide (Drug)
Patients Treated with Teriparatide
Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period.
干预措施: Teriparatide (Drug)
结局指标
主要结局
Number of Participants With a Nonvertebral Fracture
时间窗: From index date up to 19 months
A nonvertebral fracture is any fragility fracture at the hip, pelvis, femur, ankle, shoulder (including shoulder, humerus, clavicle), radius/ulna, wrist, or tibia/fibula. The date of the first prescription claim for either abaloparatide or teriparatide during the identification period was considered the index date. A claims-based algorithm with high specificity for fracture site was used to identify osteoporosis related fractures. Patients were followed for up to 18 months after their index date, plus 30 days follow-up or until their first nonvertebral fracture event or hospital death, whichever came first.
次要结局
- Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death(From index date up to 19 months)
- Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death(From index date up to 19 months)