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Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT04974723 (opens ClinicalTrials.gov in a new tab)Other idBA058-05-028
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
22,054 participants (actual)
Sponsor
Radius Health, Inc. · Industry
Design
Not stated
Countries
1 country

United States

Start
1 Jul 2021
Primary completion
30 Sept 2021
Completion
30 Sept 2021
First posted
23 Jul 2021
Last update posted
19 Apr 2024
Conditions
Osteoporosis, Postmenopausal

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022
  1. Ph –

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

    NCT04974723

    1 Jul 2021 to 30 Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • AbaloparatideDrug
  • TeriparatideDrug

Arms2

  • Other

    Patients Treated with Abaloparatide

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

  • Other

    Patients Treated with Teriparatide

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With a Nonvertebral Fracture

    Time frame · From index date up to 19 months

    Registry description

    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 outcomes(2)

  1. Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death

    Time frame · From index date up to 19 months

    Registry description

    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.

  2. Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death

    Time frame · From index date up to 19 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· From index date up to 19 months

Number of Participants With a Nonvertebral Fracture

GroupValue (Participants)
Patients Treated With ABL313
Patients Treated With TPTD333
Secondary and other outcome results(3)
Secondary outcomeCount of participants· From index date up to 19 months

Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death

GroupValue (Participants)
Patients Treated With ABL221
Patients Treated With TPTD211
Secondary outcomeCount of participants· 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

GroupValue (Participants)
Patients Treated With ABL495
Patients Treated With TPTD471
Other pre specified outcomeCount of participants· From index date up to 19 months

Number of Participants With Hip Fracture

GroupValue (Participants)
Patients Treated With ABL112
Patients Treated With TPTD125

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Patients Treated With ABLPatients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period.10 / 11,0270 / 00 / 0
Patients Treated With TPTDPatients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period.9 / 11,0270 / 00 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2022

8 results

Comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: A US administrative claims database study.

Cosman et al. 2022Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 35

PMID 35524068PMC9499892DOI 10.1007/s00198-022-06413-yPUB-35524068

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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