Clinical trial NCT04974723: Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women
Official title: A Retrospective, Observational Cohort Study Evaluating the Effectiveness and Cardiovascular Safety of Abaloparatide in Postmenopausal Women New to Anabolic Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Radius Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2021-07-23
Enrollment: 22054
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a Nonvertebral Fracture
timeFrame: From index date up to 19 months
Secondary outcomes:
measure: Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death
timeFrame: From index date up to 19 months
measure: Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death
timeFrame: From index date up to 19 months
Other outcomes:
measure: Number of Participants With Hip Fracture
timeFrame: From index date up to 19 months
Locations:
city: Boston
country: United States
facility: Radius Health
state: Massachusetts
Study officials:
References:
citation: 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.