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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Treated with Abaloparatide | Patients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period. |
| |
| Patients Treated with Teriparatide | Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abaloparatide | Drug | Abaloparatide subcutaneous (abaloparatide SC [ABL]; Tymlos®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hip Fracture | 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 up for 18 months after their index date, plus 30 days follow-up or until their first hip fracture event or hospital death, whichever came first. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radius Health | Boston | Massachusetts | 02210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35524068 | Derived | 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. |
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Propensity score (PS) matching was used to create treatment cohorts. Patients were matched using an extensive list of indicators of disease severity and fracture risk, including fracture and treatment history, as well as conditions associated with increased risk of fall and the requirement for treatments associated with poor bone health or quality.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Treated With Abaloparatide | Patients who filled ≥ 1 prescription for Abaloparatide (ABL) (TYMLOS) as their index medication during the identification period. |
| FG001 | Patients Treated With Teriparatide | Patients who filled ≥ 1 prescription for Teriparatide (TPTD) (Forteo) as their index medication during the identification period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients meeting the study inclusion/exclusion criteria and selected after PS-matching.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With ABL | Patients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period. |
| BG001 | Patients Treated With TPTD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients meeting the study inclusion/exclusion criteria and selected after PS-matching. | Posted | Count of Participants | Participants | From index date up to 19 months |
|
From index date up to 19 months
The design of this study was characterized by secondary use of data previously collected from health insurance claims. Thus, "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" data was not collected. Only deaths recorded on the hospital discharge status were available and are presented in the "All-Cause Mortality" section below. Date of the first prescription claim for either abaloparatide or teriparatide during the identification period was considered the index date.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Treated With ABL | Patients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Radius Health, Inc. | 617-551-4000 | info@radiuspharm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2021 | Nov 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000596789 | abaloparatide |
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Teriparatide | Drug | Teriparatide subcutaneous (TPTD; Forteo®) |
|
|
| 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 | 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. | From index date up to 19 months |
| From index date up to 19 months |
Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Patients Treated With TPTD | Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period. |
|
|
|
| Secondary | Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death | 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. | All patients meeting the study inclusion/exclusion criteria and selected after PS-matching. | Posted | Count of Participants | Participants | From index date up to 19 months |
|
|
|
|
| Secondary | Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death | 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. | All patients meeting the study inclusion/exclusion criteria and selected after PS-matching. | Posted | Count of Participants | Participants | From index date up to 19 months |
|
|
|
|
| Other Pre-specified | Number of Participants With Hip Fracture | 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 up for 18 months after their index date, plus 30 days follow-up or until their first hip fracture event or hospital death, whichever came first. | All patients meeting the study inclusion/exclusion criteria and selected after PS-matching. | Posted | Count of Participants | Participants | From index date up to 19 months |
|
|
|
| 10 |
| 11,027 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Patients Treated With TPTD | Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period. | 9 | 11,027 | 0 | 0 | 0 | 0 |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |