N/A
Completed N=22,054
Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women
Osteoporosis, Postmenopausal
Source: ClinicalTrials.gov NCT04974723 ↗
Enrolled (actual)
22,054
Serious AEs
—
Results posted
Apr 2024
Primary outcomePrimary: Number of Participants With a Nonvertebral Fracture — 313; 333 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Nonvertebral Fracture |
313; 333 | — |
| SECONDARY Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death |
221; 211 | — |
| SECONDARY Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death |
495; 471 | — |
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
Data sourced from ClinicalTrials.gov (NCT04974723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.