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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis, Postmenopausal
• Intervention / Treatment: Drug: Abaloparatide; Drug: Teriparatide

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.

• Study Type: Observational
• Enrollment (Actual): 22054

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02210
      • Radius Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study eligibility criteria are in alignment with the prescribing information in the FDA approved labels for both ABL and TPTD and include women with postmenopausal osteoporosis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients Treated with Abaloparatide; Patients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period.	Drug: Abaloparatide; Abaloparatide subcutaneous (abaloparatide SC [ABL]; Tymlos®); Other Names: Tymlos
Patients Treated with Teriparatide; Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period.	Drug: Teriparatide; Teriparatide subcutaneous (TPTD; Forteo®); Other Names: Forteo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From index date up to 19 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From index date up to 19 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Hip Fracture	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 up for 18 months after their index date, plus 30 days follow-up or until their first hip fracture event or hospital death, whichever came first.	From index date up to 19 months

Collaborators and Investigators

• Sponsor: Radius Health, Inc.
• Collaborators: PRA Health Sciences
• Investigators: Study Director: Setareh A. Williams, PhD, Radius Health, Inc.

Publications and helpful links

General Publications

• Cosman F, Cooper C, Wang Y, Mitlak B, Varughese S, Williams SA. Comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: A US administrative claims database study. Osteoporos Int. 2022 Aug;33(8):1703-1714. doi: 10.1007/s00198-022-06413-y. Epub 2022 May 7.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Estimated): April 19, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide; Abaloparatide
• Other Study ID Numbers: BA058-05-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No