Trial · NCT04974723
Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women
NCT04974723, Completed, Radius Health, Inc.; results first posted 2024-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women. Trials, record NCT04974723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04974723
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women
- NCT number
- NCT04974723
- Status
- Completed
- Enrollment
- 22,054 participants, actual
- Lead sponsor
- Radius Health, Inc.
- Conditions
- Osteoporosis, Postmenopausal
- Interventions
- Abaloparatide, Teriparatide
- First posted
- 2021-07-23
- Last updated
- 2024-04-19
- Results first posted
- 2024-04-19
- 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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Nonvertebral Fracture | From index date up to 19 months | 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 | 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 | 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. |
| Secondary | 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 | 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. |
| Other | Number of Participants With Hip Fracture | From index date up to 19 months | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Nonvertebral Fracture | From index date up to 19 months | All patients meeting the study inclusion/exclusion criteria and selected after PS-matching. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | All patients meeting the study inclusion/exclusion criteria and selected after PS-matching. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | All patients meeting the study inclusion/exclusion criteria and selected after PS-matching. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Hip Fracture | From index date up to 19 months | All patients meeting the study inclusion/exclusion criteria and selected after PS-matching. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Nonvertebral Fracture | Patients Treated With ABL | 313 | Participants | ||
| Number of Participants With a Nonvertebral Fracture | Patients Treated With TPTD | 333 | Participants | ||
| Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death | Patients Treated With ABL | 221 | Participants | ||
| Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death | Patients Treated With TPTD | 211 | Participants | ||
| Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death | Patients Treated With ABL | 495 | Participants | ||
| Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death | Patients Treated With TPTD | 471 | Participants | ||
| Number of Participants With Hip Fracture | Patients Treated With ABL | 112 | Participants | ||
| Number of Participants With Hip Fracture | Patients Treated With TPTD | 125 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients Treated With Abaloparatide | 11,027 | |
| Overall Study | STARTED | Patients Treated With Teriparatide | 11,027 | |
| Overall Study | COMPLETED | Patients Treated With Abaloparatide | 11,027 | |
| Overall Study | COMPLETED | Patients Treated With Teriparatide | 11,027 | |
| Overall Study | NOT COMPLETED | Patients Treated With Abaloparatide | 0 | |
| Overall Study | NOT COMPLETED | Patients Treated With Teriparatide | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients Treated With ABL | 10 | 11,027 |
| Total, all-cause mortality | Patients Treated With TPTD | 9 | 11,027 |
| Total, other adverse events | Patients Treated With ABL | 0 | 0 |
| Total, other adverse events | Patients Treated With TPTD | 0 | 0 |
| Total, serious adverse events | Patients Treated With ABL | 0 | 0 |
| Total, serious adverse events | Patients Treated With TPTD | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35524068 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Patients Treated With ABL vs Patients Treated With TPTD: Number of Participants With a Composite Endpoint of Nonfatal MI, Nonfatal Stroke, Heart Failure or In-hospital Cardiovascular Death | Trial comparisons |
| Patients Treated With ABL vs Patients Treated With TPTD: Number of Participants With a Nonvertebral Fracture | Trial comparisons |
| Patients Treated With ABL vs Patients Treated With TPTD: Number of Participants With Hip Fracture | Trial comparisons |
| Patients Treated With ABL vs Patients Treated With TPTD: deaths from any cause | Trial comparisons |
| Patients Treated With ABL vs Patients Treated With TPTD: Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04974723
GET https://conductscience.org/api/trials/v1/NCT04974723/registered