Osteoporosis, Postmenopausal
Conditions
Keywords
Osteoporosis
Brief 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. 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.
Interventions
DRUGBazedoxifene
Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
DRUGBisphosphonate
Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
DRUGRaloxifene
Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* There is no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Venous Thromboembolism (VTE) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Cardiac Disorders | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Atrial Fibrillation | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Biliary Events | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Hypertriglyceridemia | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Clinical Fractures | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Ischemic Stroke | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of All Malignancies | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Different Types of Malignancies | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Depression | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Selected Ocular Events | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Thyroid Disorders- Goitre | Up to a maximum of follow-up period of 92.1 months | 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. |
| Cumulative Incidence of Renal Failure | Up to a maximum of follow-up period of 92.1 months | 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. |
Participant flow
Recruitment details
This is a retrospective, observational, non-interventional study. Data was collected from proprietary longitudinal patient databases (LPD).
Pre-assignment details
The index date for each participant was the date of first recorded prescription for bazedoxifene, raloxifene or bisphosphonate. Follow-up period was from index date to first incident of primary event or date of last contact, whichever occurred first. Follow-up was maximum up to approximately of 92.1 months.
Participants by arm
| Arm | Count |
|---|---|
| Bazedoxifene Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | 1,111 |
| Raloxifene Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | 2,720 |
| Bisphosphonate Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity. | 6,666 |
| Total | 10,497 |
Baseline characteristics
| Characteristic | Bazedoxifene | Raloxifene | Bisphosphonate | Total |
|---|---|---|---|---|
| Age, Customized From 45-49 years | 51 Participants | 78 Participants | 88 Participants | 217 Participants |
| Age, Customized From 50-59 years | 479 Participants | 665 Participants | 915 Participants | 2059 Participants |
| Age, Customized From 60-69 years | 382 Participants | 1229 Participants | 1915 Participants | 3526 Participants |
| Age, Customized From greater than equal to (>=) 70 years | 199 Participants | 748 Participants | 3748 Participants | 4695 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 1111 Participants | 2720 Participants | 6666 Participants | 10497 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Venous Thromboembolism (VTE) | 1.5 percentage of participants |
| Raloxifene | Cumulative Incidence of Venous Thromboembolism (VTE) | 2.2 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Venous Thromboembolism (VTE) | 4.6 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: <0.0195% CI: [0.3, 0.7]Regression, Logistic
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.9195% CI: [0.4, 2.2]Regression, Logistic
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of All Malignancies | 3.2 percentage of participants |
| Raloxifene | Cumulative Incidence of All Malignancies | 4.4 percentage of participants |
| Bisphosphonate | Cumulative Incidence of All Malignancies | 6.6 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: <0.0195% CI: [0.3, 0.7]Regression, Linear
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.3895% CI: [0.5, 1.4]Regression, Linear
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Atrial Fibrillation | 2.8 percentage of participants |
| Raloxifene | Cumulative Incidence of Atrial Fibrillation | 4.3 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Atrial Fibrillation | 6.5 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.195% CI: [0.5, 1.1]Regression, Logistic
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.1995% CI: [0.4, 1.2]Regression, Logistic
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Biliary Events | 1.8 percentage of participants |
| Raloxifene | Cumulative Incidence of Biliary Events | 2 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Biliary Events | 4 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: <0.0195% CI: [0.3, 0.7]Regression, Logistic
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.995% CI: [0.4, 2.1]Regression, Linear
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Cardiac Disorders | 2 percentage of participants |
| Raloxifene | Cumulative Incidence of Cardiac Disorders | 3 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Cardiac Disorders | 6.6 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.0195% CI: [0.3, 0.9]Regression, Logistic
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.3795% CI: [0.4, 1.5]Regression, Logistic
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Clinical Fractures | 4.4 percentage of participants |
| Raloxifene | Cumulative Incidence of Clinical Fractures | 8.2 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Clinical Fractures | 12.8 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: <0.0195% CI: [0.3, 0.6]Regression, Logistic
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.0195% CI: [0.4, 0.9]Regression, Logistic
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Depression | 10.1 percentage of participants |
| Raloxifene | Cumulative Incidence of Depression | 9.2 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Depression | 8.6 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.2495% CI: [0.9, 1.5]Regression, Linear
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.5995% CI: [0.8, 1.6]Regression, Linear
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bazedoxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies - Lung | 0.3 percentage of participants |
| Bazedoxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies- Gastrointestinal | 1.1 percentage of participants |
| Bazedoxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies- Respiratory | 0.1 percentage of participants |
| Bazedoxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies - Genital / Urogenital | 0.5 percentage of participants |
| Bazedoxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies - Breast | 0.4 percentage of participants |
| Raloxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies - Genital / Urogenital | 0.4 percentage of participants |
| Raloxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies - Thyroid | 0.1 percentage of participants |
| Raloxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies - Renal | 0.1 percentage of participants |
| Raloxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies - Lung | 0.4 percentage of participants |
| Raloxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies- Gastrointestinal | 1.1 percentage of participants |
| Raloxifene | Cumulative Incidence of Different Types of Malignancies | Malignancies - Breast | 0.6 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Different Types of Malignancies | Malignancies- Respiratory | 0.1 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Different Types of Malignancies | Malignancies - Thyroid | 0.2 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Different Types of Malignancies | Malignancies - Breast | 1.4 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Different Types of Malignancies | Malignancies - Renal | 0.1 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Different Types of Malignancies | Malignancies - Genital / Urogenital | 0.5 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Different Types of Malignancies | Malignancies - Lung | 0.3 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Different Types of Malignancies | Malignancies- Gastrointestinal | 1.5 percentage of participants |
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Hypertriglyceridemia | 9.7 percentage of participants |
| Raloxifene | Cumulative Incidence of Hypertriglyceridemia | 10.6 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Hypertriglyceridemia | 6 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: <0.0195% CI: [1.4, 2.5]Regression, Logistic
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.7495% CI: [0.7, 1.3]Regression, Logistic
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Ischemic Stroke | 2.2 percentage of participants |
| Raloxifene | Cumulative Incidence of Ischemic Stroke | 2.6 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Ischemic Stroke | 6.7 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: <0.0195% CI: [0.3, 0.7]Regression, Logistic
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.7695% CI: [0.5, 2.4]Regression, Logistic
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Renal Failure | 0.8 percentage of participants |
| Raloxifene | Cumulative Incidence of Renal Failure | 2.3 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Renal Failure | 4.8 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: <0.0195% CI: [0.1, 0.5]Regression, Linear
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.0695% CI: [0.2, 1.1]Regression, Linear
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Selected Ocular Events | 8 percentage of participants |
| Raloxifene | Cumulative Incidence of Selected Ocular Events | 12.5 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Selected Ocular Events | 10.8 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.0395% CI: [0.6, 1]Regression, Logistic
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.1995% CI: [0.6, 1.1]Regression, Linear
Secondary
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.
Time frame: Up to a maximum of follow-up period of 92.1 months
Population: Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bazedoxifene | Cumulative Incidence of Thyroid Disorders- Goitre | 1.6 percentage of participants |
| Raloxifene | Cumulative Incidence of Thyroid Disorders- Goitre | 2.5 percentage of participants |
| Bisphosphonate | Cumulative Incidence of Thyroid Disorders- Goitre | 3.8 percentage of participants |
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: <0.0195% CI: [0.2, 0.5]Regression, Linear
Comparison: The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.p-value: 0.2495% CI: [0.3, 1.3]Regression, Linear