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

Radius Health, Inc.22,054 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

22,054

Conditions

Osteoporosis, Postmenopausal

Interventions

AbaloparatideDRUG

Abaloparatide subcutaneous (abaloparatide SC \[ABL\]; Tymlos®)

TeriparatideDRUG

Teriparatide subcutaneous (TPTD; Forteo®)

Eligibility

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Radius Health

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Number of Participants With a Nonvertebral Fracture

A nonvertebral fracture is any fragility fracture at the hip, pelvis, femur, ankle, shoulder (including shoulder, humerus, clavicle), radius/ulna, wrist, or tibia/fibula. The date of the first prescription claim for either abaloparatide or teriparatide during the identification period was considered the index date. A claims-based algorithm with high specificity for fracture site was used to identify osteoporosis related fractures. Patients were followed for up to 18 months after their index date, plus 30 days follow-up or until their first nonvertebral fracture event or hospital death, whichever came first.

Time frame: From index date up to 19 months

Secondary Outcomes

Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death

Cardiovascular safety was evaluated based only on events occurring from the beginning of the index period through 19 months. The date of the first prescription claim for either abaloparatide or teriparatide during the identification period was considered the index date. Cardiovascular events (MI and stroke) were defined as the first post-index incidence recorded on a hospital claim or physician claim. A validated claims-based algorithm was used to identify deaths, based on hospital discharge status, that are likely to be caused by cardiovascular events. Patients were followed for up to 18 months while on treatment plus 30 days follow-up, or until their first cardiovascular event (MI or stroke) or hospital death, whichever came first.

Time frame: From index date up to 19 months

Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death

Cardiovascular safety was evaluated based only on events occurring from the beginning of the index period through 19 months. The date of the first prescription claim for either abaloparatide or teriparatide during the identification period was considered the index date. Cardiovascular events (MI, stroke, and heart failure) were defined as the first post-index incidence recorded on a hospital claim or physician claim. A validated claims-based algorithm was used to identify deaths, based on hospital discharge status, that are likely to be caused by cardiovascular events. Patients were followed for up to 18 months while on treatment plus 30 days follow-up, or until their first cardiovascular event (MI, stroke, or heart failure) or hospital death, whichever came first.

Data from ClinicalTrials.gov

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