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

Radius Health

Status: Completed

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: Teriparatide; Drug: Abaloparatide

Study type: Observational

Funder types: Industry

Identifiers

NCT04974723

BA058-05-028

Details and patient eligibility

About

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

Full 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.

Enrollment: 22,054 patients

Sex: Female

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

22,054 participants in 2 patient groups

Patients Treated with Abaloparatide

Description:

Patients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period.

Treatment:

Drug: Abaloparatide

Patients Treated with Teriparatide

Description:

Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period.

Treatment:

Drug: Teriparatide