Status:
COMPLETED
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Osteoporosis
Eligibility:
FEMALE
65+ years
Brief Summary
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 cl...
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- Criteria:
- Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
- Eligible cohort entry dates:
- Zoledronic acid indication for treatment of postmenopausal women with osteoporosis was approved by FDA on Aug 20, 2007.
- For IBM MarketScan: Aug 21, 2007 - December 31, 2018 (end of available data)
- For Optum CDM: Aug 21, 2007 - Mar 31, 2020 (end of available data)
- Postmenopausal women between the ages of 65 and 89 years
- Osteoporosis diagnosis
Exclusion
- 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
Key Trial Info
Start Date :
September 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 18 2021
Estimated Enrollment :
18028 Patients enrolled
Trial Details
Trial ID
NCT04736693
Start Date
September 22 2020
End Date
February 18 2021
Last Update
July 27 2023
Active Locations (1)
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1
Brigham And Women's Hospital
Boston, Massachusetts, United States, 02120