NCT04974723

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22,054 (actual)
• Sponsor: Radius Health, Inc. · Industry
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	Abaloparatide	Abaloparatide subcutaneous (abaloparatide SC \[ABL\]; Tymlos®)
DRUG	Teriparatide	Teriparatide subcutaneous (TPTD; Forteo®)

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2021-07-23
• Last updated: 2024-04-19
• Results posted: 2024-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study