Osteoporosis, PostmenopausalNCT01416194
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
An observational study of Osteoporosis, Postmenopausal, run by Pfizer.
Trial summary
This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Bazedoxifene, Bisphosphonate and Raloxifene
- How many people
- 10,497 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2011to 30 Apr 2019
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 45 or over who have records of receiving bazedoxifene, bisphosphonates or raloxifene in the Cegedim database in Italy and Spain.
Who may be able to join
- Female
- At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);
- A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;
- Age >=45 at the date of the index prescription; and
- At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription
Who cannot join
- There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.
About this study
Official title: COHORT STUDY OF VENOUS THROMBOEMBOLISM AND OTHER CLINICAL ENDPOINTS AMONG OSTEOPOROTIC WOMEN PRESCRIBED BAZEDOXIFENE, BISPHOSPHONATES OR RALOXIFENE IN EUROPE
This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups.
Read the detailed description
All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Bazedoxifene, Bisphosphonate, Raloxifene
- Keywords
- Osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BazedoxifeneDrug
Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
BisphosphonateDrug
Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
RaloxifeneDrug
Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| Bazedoxifene | Not described Receives: Drug: Bazedoxifene | |
| Primary Comparator | Not described Receives: Drug: Bisphosphonate | |
| Secondary Comparator | Not described Receives: Drug: Raloxifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Venous Thromboembolism (VTE)
VTE is defined as deep vein thrombosis (DVT), pulmonary embolism (PE), retinal vein thrombosis, and sinus thrombosis. DVT: occurs when a blood clot forms in a vein located deep inside the body. PE: a blockage of an artery in the lungs by a substance that has moved from elsewhere in the body through the bloodstream (embolism). Sinus thrombosis: presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Retinal vein thrombosis: blockage of the small veins that carry blood away from the retina. Cumulative incidence was calculated as total participants with VTE events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Secondary outcomes (12)
Cumulative Incidence of Ischemic Stroke
Ischemic stroke is caused by a blockage in an artery that supplies blood to the brain. Cumulative incidence was calculated as total participants with ischemic stroke events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Cardiac Disorders
Cardiac disorders included myocardial infarction, myocardial ischemia, and coronary occlusion. Cumulative incidence was calculated as total participants with cardiac disorders events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Atrial Fibrillation
Atrial fibrillation is an irregular heartbeat that increases the risk of stroke and heart disease. Cumulative incidence was calculated as total participants with atrial fibrillation events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Biliary Events
Biliary events included cholecystitis and cholelithiasis. Cumulative incidence was calculated as total participants with biliary events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Hypertriglyceridemia
Hypertriglyceridemia refers to high blood levels of triglycerides. Cumulative incidence was calculated as total participants with hypertriglyceridemia events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Clinical Fractures
A fracture is a break in a bone. Cumulative incidence was calculated as total participants with clinical fractures events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Renal Failure
Cumulative incidence was calculated as total participants with renal failure events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of All Malignancies
All malignancies included and not limited only to thyroid, breast, renal, genital / urogenital, lung cancer, gastrointestinal tract and respiratory tract. Cumulative incidence was calculated as total participants with malignancies events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Different Types of Malignancies
In this outcome measure, cumulative incidence of different types of malignancies included breast, renal, thyroid, genital / urogenital, gastrointestinal tract, lung and respiratory tract were calculated. Cumulative incidence for each type of malignancy was calculated as total participant with the respective malignancy events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence for each type of malignancy was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Depression
Cumulative incidence was calculated as total participants with depression events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Selected Ocular Events
Selected ocular events included retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. Cumulative incidence was calculated as total participants with selected ocular events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Thyroid Disorders- Goitre
Goitre is a swelling in the neck resulting from an enlarged thyroid gland. Cumulative incidence was calculated as total participants with thyroid disorders-goitre events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
Measured: Up to a maximum of follow-up period of 92.1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study start25 Jul 2011
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
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.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 10,497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416194
- Sponsor's protocol ID
- B1781044
- Status last verified
- Apr 2024
- First submitted
- 11 Aug 2011
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COHORT STUDY OF VENOUS THROMBOEMBOLISM AND OTHER CLINICAL ENDPOINTS AMONG OSTEOPOROTIC WOMEN PRESCRIBED BAZEDOXIFENE, BISPHOSPHONATES OR RALOXIFENE IN EUROPE
- ClinicalTrials.gov ID
- NCT01416194
- Acronym / sponsor ID
- B1781044
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,497 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2011 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Posted 18 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups.
Detailed description
All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bazedoxifene | – | Drug: Bazedoxifene |
| Primary Comparator | – | Drug: Bisphosphonate |
| Secondary Comparator | – | Drug: Raloxifene |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 45 or over who have records of receiving bazedoxifene, bisphosphonates or raloxifene in the Cegedim database in Italy and Spain.
Key inclusion criteria (5 listed)
- Female
- At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);
- A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;
- Age >=45 at the date of the index prescription; and
- At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription
Key exclusion criteria (1 listed)
- There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.
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 |
|---|---|---|
| BazedoxifenePatients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule. | Drug | Bazedoxifene |
| BisphosphonatePatients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule. | Drug | Primary Comparator |
| RaloxifenePatients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule. | Drug | Secondary Comparator |
Primary outcome
Cumulative Incidence of Venous Thromboembolism (VTE)
Time frame: Up to a maximum of follow-up period of 92.1 months
VTE is defined as deep vein thrombosis (DVT), pulmonary embolism (PE), retinal vein thrombosis, and sinus thrombosis. DVT: occurs when a blood clot forms in a vein located deep inside the body. PE: a blockage of an artery in the lungs by a substance that has moved from elsewhere in the body through the bloodstream (embolism). Sinus thrombosis: presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Retinal vein thrombosis: blockage of the small veins that carry blood away from the retina. Cumulative incidence was calculated as total participants with VTE events during follow-up period divided by total persons at risk during follow-up period*100 and hence cumulative incidence was expressed as percentage of participants.
12 secondary outcomes
Cumulative Incidence of Ischemic Stroke
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Cardiac Disorders
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Atrial Fibrillation
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Biliary Events
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Hypertriglyceridemia
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Clinical Fractures
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Renal Failure
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of All Malignancies
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Different Types of Malignancies
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Depression
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Selected Ocular Events
Time frame: Up to a maximum of follow-up period of 92.1 months
Cumulative Incidence of Thyroid Disorders- Goitre
Time frame: Up to a maximum of follow-up period of 92.1 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Osteoporosis, Postmenopausal
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis
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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal, run by Pfizer.
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 5 inclusion and 1 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 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 18 May 2020). 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?
Cumulative Incidence of Venous Thromboembolism (VTE) (time frame: Up to a maximum of follow-up period of 92.1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2024.