An observational study in Osteoporosis, sponsored by Pfizer. Completed at 60 sites in Korea, Republic of. Open to female participants. Per ClinicalTrials.gov, last updated 2018-12-24.
Sponsored by Pfizer · Observational
This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for New Drugs
continuous enrollment
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 3,430 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.
Postmenopausal osteoporosis and osteopenia patients
Exclusion Criteria:
Viviant treatment group
Drug: Viviant
Viviant (Bazedoxifene) 20mg once daily
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Time frame: Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)
Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.
Time frame: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)
Overall Efficacy Evaluation of Viviant 20 mg Tablet
Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy.
Time frame: Baseline up to 3 months
Number of Participants With Osteoporosis Related Fractures
Time frame: Baseline up to 3 months
Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)
DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
Time frame: Baseline up to 3 months
Number of Participants With Abnormal X-ray Result
Criteria for abnormality was based on investigator's discretion.
Time frame: Baseline up to 3 months
Number of Participants With Abnormal Bone Mineral Density Result
A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.
Time frame: Baseline up to 3 months
Number of Participants With Abnormal Biochemical Markers of Bone Turnover
In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.
Time frame: Baseline up to 3 months
| Milestone | Viviant Tablet 20 mg |
|---|---|
| Started | 3430 |
| Treated | 3423 |
| Completed | 3423 |
| Not completed | 7 |
| Withdrew: Randomized not treated | 7 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
| Participants | Viviant Tablet 20 mg |
|---|---|
| AEs | 209 |
| SAEs | 17 |
Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy.
| Participants | Viviant Tablet 20 mg |
|---|---|
| Improved | 1283 |
| No change | 1814 |
| Worsened | 14 |
| Unevaluable | 0 |
| Participants | Viviant Tablet 20 mg |
|---|---|
| Number of Participants With Osteoporosis Related Fractures | 4 |
DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
| Participants | Viviant Tablet 20 mg |
|---|---|
| Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA) | 7 |
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator.
| Participants | Viviant Tablet 20 mg |
|---|---|
| ADRs | 132 |
| Serious ADRs | 3 |
| Unexpected ADRs | 93 |
Criteria for abnormality was based on investigator's discretion.
| Participants | Viviant Tablet 20 mg |
|---|---|
| Number of Participants With Abnormal X-ray Result | 0 |
A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.
| Participants | Viviant Tablet 20 mg |
|---|---|
| Number of Participants With Abnormal Bone Mineral Density Result | 0 |
In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.
| Participants | Viviant Tablet 20 mg |
|---|---|
| CTX | 0 |
| Osteocalcin | 0 |
| Bone specific alkaline phosphatase | 0 |
Collected over Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Viviant Tablet 20 mg | 1/3,423 (0%) | 17/3,423 (0.5%) | 192/3,423 (5.6%) |
| Event | Viviant Tablet 20 mg |
|---|---|
| PYELONEPHRITISInfections and infestations | 3/3423 |
| FRACTUREMusculoskeletal and connective tissue disorders | 2/3423 |
| CEREBRAL INFARCTIONVascular disorders | 2/3423 |
| SPINAL STENOSISNervous system disorders | 1/3423 |
| BRADYCARDIACardiac disorders | 1/3423 |
| ABDOMINAL PAINGastrointestinal disorders | 1/3423 |
| DEATHGeneral disorders | 1/3423 |
| FATIGUEGeneral disorders | 1/3423 |
| FEVERGeneral disorders | 1/3423 |
| OEDEMA GENERALISEDGeneral disorders | 1/3423 |
| Event | Viviant Tablet 20 mg |
|---|---|
| DYSPEPSIAGastrointestinal disorders | 51/3423 |
| NAUSEAGastrointestinal disorders | 13/3423 |
| FLUSHINGVascular disorders | 13/3423 |
| MOUTH DRYGastrointestinal disorders | 8/3423 |
| PRURITUSSkin and subcutaneous tissue disorders | 8/3423 |
| ABDOMINAL PAINGastrointestinal disorders | 7/3423 |
| HEADACHENervous system disorders | 6/3423 |
| OEDEMA PERIPHERALGeneral disorders | 6/3423 |
| PHARYNGITISInfections and infestations | 6/3423 |
| MYALGIAMusculoskeletal and connective tissue disorders | 6/3423 |
Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.
| Age, Continuous(years) | Viviant Tablet 20 mg |
|---|---|
| Mean Age | 69.51 ± 10.03 |
| Sex: Female, Male(Participants) | Viviant Tablet 20 mg |
|---|---|
| Female | 3423 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Viviant Tablet 20 mg |
|---|
| Weight Continuous(kilograms) | Viviant Tablet 20 mg |
|---|---|
| Mean | 55.12 ± 8.26 |
| Height Continuous(centimeter) | Viviant Tablet 20 mg |
|---|---|
| Mean | 153.56 ± 5.87 |
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