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

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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