Osteoporosis
Conditions
Keywords
Osteoporosis, Post menopausal women, SERM, Japanese, Viviant, Regulatory Post Marketing Commitment Plan, Long term treatment
Brief summary
In this survey, to collect the safety and efficacy information of Bazedoxifene in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.
Detailed description
All the subjects whom an investigator prescribes the first Bazedoxifene (Viviant) Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Interventions
DRUGBazedoxifene
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Post menopausal women subjects with Osteoporosis who has no experience of use of Bazedoxifene.
Exclusion criteria
* Subject with present or past venous thromboembolism such as deep venous thrombosis, pulmonary embolism, or retinal venous thrombosis * Subject in long-term immovability (postoperative recovery, long-term bed rest) * Subject with antiphospholipid antibody syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | 3 years | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician. |
| Number of Participants With Any Fracture | 3 years | Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included fracture in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events by Smoking Status | 3 years | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events. |
| Number of Participants With Treatment-Related Adverse Events by Use of Steroid | 3 years | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events. |
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 3 years | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Viviant was assessed by the physician. |
| Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication | 3 years | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events. |
| Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication | 3 years | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events. |
| Number of Participants With Treatment-Related Adverse Events by Age | 3 years | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Viviant (Bazedoxifene Acetate) Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion. | 3,034 |
| Total | 3,034 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No Drug Administration Information | 2 |
| Overall Study | No Visit After 1st Day of Treatment | 119 |
| Overall Study | Protocol Violation | 32 |
Baseline characteristics
| Characteristic | Viviant (Bazedoxifene Acetate) |
|---|---|
| Age, Customized ≥15 and <65 years | 514 Participants |
| Age, Customized <15 years | 0 Participants |
| Age, Customized ≥65 years | 2520 Participants |
| Fracture History No | 1807 Participants |
| Fracture History Unknown | 385 Participants |
| Fracture History Yes | 842 Participants |
| Sex: Female, Male Female | 3034 Participants |
| Sex: Female, Male Male | 0 Participants |
| Smoking Status Non-Smoker | 2211 Participants |
| Smoking Status Smoker | 94 Participants |
| Smoking Status Unknown | 729 Participants |
| Use of Concomitant Medication No | 931 Participants |
| Use of Concomitant Medication Yes | 2103 Participants |
| Use of Previous Medication No | 1647 Participants |
| Use of Previous Medication Unknown | 116 Participants |
| Use of Previous Medication Yes | 1271 Participants |
| Use of Steroid No | 2523 Participants |
| Use of Steroid Unknown | 410 Participants |
| Use of Steroid Yes | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 83 / 3,034 |
| serious Total, serious adverse events | 95 / 3,034 |
Outcome results
Primary
Number of Participants With Any Fracture
Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included fracture in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1.
Time frame: 3 years
Population: The effectiveness analysis set was identical with the safety analysis set which comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Viviant (Bazedoxifene Acetate) | Number of Participants With Any Fracture | 53 Participants |
Primary
Number of Participants With Treatment-Related Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician.
Time frame: 3 years
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events | Treatment-related Adverse Event | 137 Participants |
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events | Treatment-related Serious Adverse Event | 5 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events by Age
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time frame: 3 years
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Age | ≥15 and <65 years | 25 Participants |
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Age | ≥65 years | 112 Participants |
| Unknown | Number of Participants With Treatment-Related Adverse Events by Age | <15 years | — Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events by Smoking Status
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time frame: 3 years
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Smoking Status | Smoker | 0 Participants |
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Smoking Status | Non-Smonker | 85 Participants |
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Smoking Status | Unknown | 52 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.
Time frame: 3 years
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication | Yes | 101 Participants |
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication | No | 36 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.
Time frame: 3 years
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication | Yes | 66 Participants |
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication | No | 64 Participants |
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication | Unknown | 7 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events by Use of Steroid
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events.
Time frame: 3 years
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Use of Steroid | Yes | 13 Participants |
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Use of Steroid | No | 99 Participants |
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events by Use of Steroid | Unknown | 25 Participants |
Secondary
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Viviant was assessed by the physician.
Time frame: 3 years
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Viviant (Bazedoxifene Acetate) | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 80 Participants |