Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18,028
- 试验地点
- 1
- 主要终点
- Number of patients with hip fracture
研究概览
简要总结
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
详细描述
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women between the ages of 65 and 89 years
- •Osteoporosis diagnosis
排除标准
- •Bisphosphonate users
- •Previous use of:
- •Any use of parathyroid hormone
- •Use of anabolic steroids or growth hormone within 6 months before cohort entry date OR
- •Use of oral or intravenous systemic corticosteroids within 12 months of cohort entry date
- •Serious disease that may limit life expectancy to less than 6 months
- •Malignant neoplasm diagnosis within 12 months prior to the cohort entry date
- •Conditions that influence bone metabolism
- •Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
- •Treatment of Paget's Disease of Bone
- •Alcohol abuse/dependence OR Drug abuse/dependence OR Non-compliance
- •Pregnancy
- •Diagnosis and procedure for amputee of lower limb
- •Use of Zoledronic acid within 450 days prior to the cohort entry date
- •Use of Denosumab within 450 days prior to the cohort entry date
- •Diagnosis of End-Stage Renal Disease OR Diagnosis and procedure for Kidney transplant
- •Diagnosis of End-Stage Liver Disease: Cirrhosis, Hepatic decompensation
- •Blindness or compromised vision
- •Use of Abaloparatide within 450 days prior to the cohort entry date
- •Use of Romosozumab within 450 days prior to the cohort entry date
研究组 & 干预措施
Raloxifene
Reference Group
干预措施: Raloxifene (Drug)
Zoledronic Acid
Exposure Group
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Number of patients with hip fracture
时间窗: Through study completion (earliest of 540 days or censoring)
Please refer to attached protocol for full definition due to size limitations
次要结局
- Number of patients with non-vertebral fracture(Through study completion (earliest of 540 days or censoring))
研究者
Shirley Vichy Wang
Associate Professor of Medicine
Brigham and Women's Hospital