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

NCT04974723 | Completed Results FDA Drug

• 1 other identifier: BA058-05-028
• Study Type: observational
• Target: 22,054
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  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

  From index date up to 19 months

Other Outcomes (1)

• Number of Participants With Hip Fracture

  From index date up to 19 months

Study Arms (2)

Patients Treated with Abaloparatide

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

Drug: Abaloparatide

Patients Treated with Teriparatide

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

Drug: Teriparatide

Interventions

Abaloparatide DRUG

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

Also known as: Tymlos

Patients Treated with Abaloparatide

Teriparatide DRUG

Teriparatide subcutaneous (TPTD; Forteo®)

Also known as: Forteo

Patients Treated with Teriparatide

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radius Health, Inc.: lead
• PRA Health Sciences: collaborator

Study Sites (1)

Radius Health

Boston, Massachusetts, 02210, United States

Location

Related Publications (1)

• 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.

  PMID: 35524068 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

abaloparatide; Teriparatide

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This was a non-controlled, non-randomized study. The data source was administrative claims data that was not collected for research purposes and included potential inaccuracies related to use of prescription medications. Only deaths recorded on the hospital discharge status were available for the derivation of cardiovascular death in this study. Detailed clinical data such as BMD values were not available, and unknown confounding factors were not adjusted for in propensity score matching.

Results Point of Contact

• Title: Clinical Operations
• Organization: Radius Health, Inc.

info@radiuspharm.com

617-551-4000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 23, 2021
• Study Start: July 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 19, 2024
• Results First Posted: April 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)