Osteoporosis, PostmenopausalNCT04974723
Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women
An observational study of Osteoporosis, Postmenopausal, run by Radius Health, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Abaloparatide and Teriparatide
- Type of treatment
- Injection or infusion
- How many people
- 22,054 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 30 Sep 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Observational Cohort Study Evaluating the Effectiveness and Cardiovascular Safety of Abaloparatide in Postmenopausal Women New to Anabolic Therapies
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
Read the 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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Abaloparatide, Teriparatide
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbaloparatideDrug
Also called Tymlos
Abaloparatide subcutaneous (abaloparatide SC [ABL]; Tymlos®)
TeriparatideDrug
Also called Forteo
Teriparatide subcutaneous (TPTD; Forteo®)
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated with Abaloparatide | Patients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period. Receives: Drug: Abaloparatide | |
| Patients Treated with Teriparatide | Patients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period. Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: From index date up to 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radius Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974723
- Sponsor's protocol ID
- BA058-05-028
- Status last verified
- Oct 2023
- First submitted
- 18 Jun 2021
- Last updated
- 19 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35524068
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational Cohort Study Evaluating the Effectiveness and Cardiovascular Safety of Abaloparatide in Postmenopausal Women New to Anabolic Therapies
- ClinicalTrials.gov ID
- NCT04974723
- Acronym / sponsor ID
- BA058-05-028
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,054 participants (actual)
- Lead sponsor
- Radius Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 19 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Treated with Abaloparatide | – | Drug: AbaloparatidePatients who filled ≥ 1 prescription for ABL (TYMLOS) as their index medication during the identification period. |
| Patients Treated with Teriparatide | – | Drug: TeriparatidePatients who filled ≥ 1 prescription for TPTD (Forteo) as their index medication during the identification period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbaloparatideAlso: TymlosAbaloparatide subcutaneous (abaloparatide SC [ABL]; Tymlos®) | Drug | Patients Treated with Abaloparatide |
| TeriparatideAlso: ForteoTeriparatide subcutaneous (TPTD; Forteo®) | Drug | Patients Treated with Teriparatide |
Primary outcome
Number of Participants With a Nonvertebral Fracture
Time frame: 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.
2 secondary outcomes
Number of Participants With Composite Endpoint of Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or In-hospital Cardiovascular Death
Time frame: 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
Time frame: From index date up to 19 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35524068Cosman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal, run by Radius Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Nonvertebral Fracture (time frame: From index date up to 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04974723, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.