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

Completed

Conditions: Osteoporosis, Postmenopausal

Interventions: Drug: Teriparatide
Drug: Abaloparatide

Registration Number: NCT04974723

Lead Sponsor: Radius Health, Inc.

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 22054

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Treated with Teriparatide	Teriparatide	Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period.
Patients Treated with Abaloparatide	Abaloparatide	Patients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Nonvertebral Fracture	From index date up to 19 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death	From index date up to 19 months	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.
Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death	From index date up to 19 months	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.