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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22054 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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 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.

Conditions

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Osteoporosis, Postmenopausal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients Treated with Abaloparatide

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

Abaloparatide

Intervention Type DRUG

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

Patients Treated with Teriparatide

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

Teriparatide

Intervention Type DRUG

Teriparatide subcutaneous (TPTD; Forteo®)

Interventions

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Abaloparatide

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

Intervention Type DRUG

Teriparatide

Teriparatide subcutaneous (TPTD; Forteo®)

Intervention Type DRUG

Other Intervention Names

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Tymlos Forteo

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No