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Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women

Osteoporosis, Postmenopausal Clinical Trial

Official title:
A Retrospective, Observational Cohort Study Evaluating the Effectiveness and Cardiovascular Safety of Abaloparatide in Postmenopausal Women New to Anabolic Therapies

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04974723
Study type Observational
Source Radius Health, Inc.
Contact
Status Completed
Phase
Start date July 1, 2021
Completion date September 30, 2021
View Details
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