An observational study in Osteoporosis, sponsored by Pfizer. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2018-11-05.
Sponsored by Pfizer · Observational
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.
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 3,187 is above the median of 174 across 446 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
The subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets.
Exclusion Criteria:
Subjects taking Bazedoxifene Tablets
Drug: Bazedoxifene
For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.
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
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
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
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
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
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
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
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
| Milestone | Viviant (Bazedoxifene Acetate) |
|---|---|
| Started | 3187 |
| Completed | 3034 |
| Not completed | 153 |
| Withdrew: Protocol violation | 32 |
| Withdrew: No drug administration information | 2 |
| Withdrew: No visit after 1st day of treatment | 119 |
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.
| Participants | Viviant (Bazedoxifene Acetate) |
|---|---|
| Treatment-related Adverse Event | 137 |
| Treatment-related Serious Adverse Event | 5 |
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.
| Participants | Viviant (Bazedoxifene Acetate) |
|---|---|
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | 80 |
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.
| Participants | Viviant (Bazedoxifene Acetate) |
|---|---|
| ≥15 and <65 years | 25 |
| ≥65 years | 112 |
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.
| Participants | Viviant (Bazedoxifene Acetate) |
|---|---|
| Smoker | 0 |
| Non-Smonker | 85 |
| Unknown | 52 |
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.
| Participants | Viviant (Bazedoxifene Acetate) |
|---|---|
| Yes | 13 |
| No | 99 |
| Unknown | 25 |
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.
| Participants | Viviant (Bazedoxifene Acetate) |
|---|---|
| Yes | 66 |
| No | 64 |
| Unknown | 7 |
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.
| Participants | Viviant (Bazedoxifene Acetate) |
|---|---|
| Number of Participants With Any Fracture | 53 |
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.
| Participants | Viviant (Bazedoxifene Acetate) |
|---|---|
| Yes | 101 |
| No | 36 |
Non-serious events are listed at a 0.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Viviant (Bazedoxifene Acetate) | — | 95/3,034 (3.1%) | 83/3,034 (2.7%) |
| Event | Viviant (Bazedoxifene Acetate) |
|---|---|
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 8/3034 |
| Cerebral infarctionNervous system disorders | 5/3034 |
| Femoral neck fractureInjury, poisoning and procedural complications | 5/3034 |
| Femur fractureInjury, poisoning and procedural complications | 5/3034 |
| Lumbar vertebral fractureInjury, poisoning and procedural complications | 5/3034 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/3034 |
| Cardiac failureCardiac disorders | 4/3034 |
| Cardiac failure acuteCardiac disorders | 4/3034 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/3034 |
| DeathGeneral disorders | 4/3034 |
| Event | Viviant (Bazedoxifene Acetate) |
|---|---|
| Back painMusculoskeletal and connective tissue disorders | 25/3034 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 20/3034 |
| Spinal osteoarthritisMusculoskeletal and connective tissue disorders | 20/3034 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 18/3034 |
| Age, Customized(Participants) | Viviant (Bazedoxifene Acetate) |
|---|---|
| <15 years | 0 |
| ≥15 and <65 years | 514 |
| ≥65 years | 2520 |
| Sex: Female, Male(Participants) | Viviant (Bazedoxifene Acetate) |
|---|---|
| Female | 3034 |
| Male | 0 |
| Smoking Status(Participants) | Viviant (Bazedoxifene Acetate) |
|---|---|
| Smoker | 94 |
| Non-Smoker | 2211 |
| Unknown | 729 |
| Use of Steroid(Participants) | Viviant (Bazedoxifene Acetate) |
|---|---|
| Yes | 101 |
| No | 2523 |
| Unknown | 410 |
| Use of Previous Medication(Participants) | Viviant (Bazedoxifene Acetate) |
|---|---|
| Yes | 1271 |
| No | 1647 |
| Unknown | 116 |
| Use of Concomitant Medication(Participants) | Viviant (Bazedoxifene Acetate) |
|---|---|
| Yes | 2103 |
| No | 931 |
| Fracture History(Participants) | Viviant (Bazedoxifene Acetate) |
|---|---|
| Yes | 842 |
| No | 1807 |
| Unknown | 385 |
No study locations are listed for this record.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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