Eligibility, female only, with Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)
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 relativ
AEs
Group
Value
95% CI
Viviant Tablet 20 mg
209
SAEs
Group
Value
95% CI
Viviant Tablet 20 mg
17
Overall Efficacy Evaluation of Viviant 20 mg TabletSecondary· Baseline up to 3 months
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.
Improved
Group
Value
95% CI
Viviant Tablet 20 mg
1283
No change
Group
Value
95% CI
Viviant Tablet 20 mg
1814
Worsened
Group
Value
95% CI
Viviant Tablet 20 mg
14
Unevaluable
Group
Value
95% CI
Viviant Tablet 20 mg
0
Number of Participants With Osteoporosis Related FracturesSecondary· Baseline up to 3 months
Group
Value
95% CI
Viviant Tablet 20 mg
4
Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)Secondary· Baseline up to 3 months
DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.
Group
Value
95% CI
Viviant Tablet 20 mg
7
Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRsPrimary· Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)
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 r
ADRs
Group
Value
95% CI
Viviant Tablet 20 mg
132
Serious ADRs
Group
Value
95% CI
Viviant Tablet 20 mg
3
Unexpected ADRs
Group
Value
95% CI
Viviant Tablet 20 mg
93
Number of Participants With Abnormal X-ray ResultSecondary· Baseline up to 3 months
Criteria for abnormality was based on investigator's discretion.
Group
Value
95% CI
Viviant Tablet 20 mg
0
Number of Participants With Abnormal Bone Mineral Density ResultSecondary· Baseline up to 3 months
A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.
Group
Value
95% CI
Viviant Tablet 20 mg
0
Number of Participants With Abnormal Biochemical Markers of Bone TurnoverSecondary· Baseline up to 3 months
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.
CTX
Group
Value
95% CI
Viviant Tablet 20 mg
0
Osteocalcin
Group
Value
95% CI
Viviant Tablet 20 mg
0
Bone specific alkaline phosphatase
Group
Value
95% CI
Viviant Tablet 20 mg
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 24 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01793142.