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

Study Overview
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Brief Summary
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The purpose of the current study is to evaluate the real-world comparative 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
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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. 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 study intake period was chosen to coincide with the date of the FDA approval of ABL in the USA. This study will use anonymized patient claims data from the Symphony Health Patient Source IDV database including the enhanced hospital data. This retrospective cohort study is expected to include a total of 16,000 patients; 8000 patients per treatment cohort (ABL or TPTD).

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

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Drug: Abaloparatide
* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are 50 years or older ≥1 prescription fill for ABL or TPTD ≥ 1 claim for medical or hospital visit and a pharmacy claim Exclusion Criteria: Paget's disease Malignancy Indicators of high disease burden and high risk of death With prior index anabolic treatment Switch to a different anabolic treatment after index

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients Treated with Abaloparatide<br>Patients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period. | Drug: Abaloparatide<br>* Abaloparatide subcutaneous (abaloparatide SC [ABL]; Tymlos®)<br>* Other names: Tymlos;|
| Patients Treated with Teriparatide<br>Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period. | Drug: Teriparatide<br>* Teriparatide subcutaneous (TPTD; Forteo®)<br>* Other names: Forteo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first incidence of nonvertebral fracture | Time to the first incidence of nonvertebral fracture (hip, pelvis, shoulder, radius or ulna, wrist, femur, tibia or fibula, ankle) within the 18 months after treatment initiation. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first incidence of a composite of nonfatal MI, nonfatal stroke, or in-hospital cardiovascular death | Time to the first incidence of a composite of nonfatal MI, nonfatal stroke, or in-hospital cardiovascular death within the 18 months | 18 months | 
| Time to the first incidence of a composite nonfatal MI, nonfatal stroke, heart failure or in-hospital cardiovascular death | Time to the first incidence of a composite nonfatal MI, nonfatal stroke, heart failure or in-hospital cardiovascular death within the 18 months. | 18 months |