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

Sponsor
Radius Health, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04974723
Collaborator
PRA Health Sciences (Industry)
16,000
Enrollment
1
Location
3
Anticipated Duration (Months)
5351.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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. 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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
16000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective, Observational Cohort Study Evaluating the Effectiveness and Cardiovascular Safety of Abaloparatide in Postmenopausal Women New to Anabolic Therapies
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to first incidence of nonvertebral fracture [18 months]

      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.

    Secondary Outcome Measures

    1. Time to the first incidence of a composite of nonfatal MI, nonfatal stroke, or in-hospital cardiovascular death [18 months]

      Time to the first incidence of a composite of nonfatal MI, nonfatal stroke, or in-hospital cardiovascular death within the 18 months

    2. Time to the first incidence of a composite nonfatal MI, nonfatal stroke, heart failure or in-hospital cardiovascular death [18 months]

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

    Other Outcome Measures

    1. Time to first incidence of hip fracture [18 months]

      Time to first incidence of hip fracture within 18 months.

    2. Time to first incidence of MI, stroke, in-hospital cardiovascular death or heart failure [18 months]

      Time to first incidence of MI, stroke, in-hospital cardiovascular death or heart failure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radius Health Boston Massachusetts United States 02210

    Sponsors and Collaborators

    • Radius Health, Inc.
    • PRA Health Sciences

    Investigators

    • Study Director: Setareh A. Williams, PhD, Radius Health, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radius Health, Inc.
    ClinicalTrials.gov Identifier:
    NCT04974723
    Other Study ID Numbers:
    • BA058-05-028
    First Posted:
    Jul 23, 2021
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal
    Teriparatide
    Abaloparatide

    Study Results

    No Results Posted as of Aug 19, 2021