VIOLINE: Viviant 20mg Special Investigation (Regulatory Post Marketing Commitment Plan)

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01470326
• Collaborator: (none)
• Enrollment: 3,187
• Actual Duration (Months): 55

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Bazedoxifene

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 3187 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Viviant®20mg Special Investigation (Regulatory Post Marketing Commitment Plan)
• Actual Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Bazedoxifene Tablets Subjects taking Bazedoxifene Tablets	Drug: Bazedoxifene; For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01470326
• Other Study ID Numbers: B1781007
• First Posted: Nov 11, 2011
• Last Update Posted: Nov 5, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Pfizer: Osteoporosis; Post menopausal women; SERM; Japanese; Viviant; Regulatory Post Marketing Commitment Plan; Long term treatment
• Additional relevant MeSH terms: Osteoporosis; Bazedoxifene

Study Results

Participant Flow

Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	3187
COMPLETED	3034
NOT COMPLETED	153

Baseline Characteristics

Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Overall Participants	3034
Age, Customized (Count of Participants)
<15 years	0 0%
≥15 and <65 years	514 16.9%
≥65 years	2520 83.1%
Sex: Female, Male (Count of Participants)
Female	3034 100%
Male	0 0%
Smoking Status (Count of Participants)
Smoker	94 3.1%
Non-Smoker	2211 72.9%
Unknown	729 24%
Use of Steroid (Count of Participants)
Yes	101 3.3%
No	2523 83.2%
Unknown	410 13.5%
Use of Previous Medication (Count of Participants)
Yes	1271 41.9%
No	1647 54.3%
Unknown	116 3.8%
Use of Concomitant Medication (Count of Participants)
Yes	2103 69.3%
No	931 30.7%
Fracture History (Count of Participants)
Yes	842 27.8%
No	1807 59.6%
Unknown	385 12.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.

Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Measure Participants	3034
Treatment-related Adverse Event	137 4.5%
Treatment-related Serious Adverse Event	5 0.2%

2. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.

Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Measure Participants	3034
Number [Participants]	80 2.6%

3. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Age
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.

Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Measure Participants	3034
≥15 and <65 years	25 0.8%
≥65 years	112 3.7%

4. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Smoking Status
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.

Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Measure Participants	3034
Smoker	0 0%
Non-Smonker	85 2.8%
Unknown	52 1.7%

5. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Use of Steroid
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.

Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Measure Participants	3034
Yes	13 0.4%
No	99 3.3%
Unknown	25 0.8%

6. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.

Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Measure Participants	3034
Yes	66 2.2%
No	64 2.1%
Unknown	7 0.2%

7. Primary Outcome

Title	Number of Participants With Any Fracture
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Measure Participants	3034
Count of Participants [Participants]	53 1.7%

8. Secondary Outcome

Title	Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication
Description	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

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.

Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
Measure Participants	3034
Yes	101 3.3%
No	36 1.2%

Adverse Events

Adverse Event Reporting Description	The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events during the study.
Arm/Group Title	Viviant (Bazedoxifene Acetate)
Arm/Group Description	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.
All Cause Mortality
	Viviant (Bazedoxifene Acetate)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Viviant (Bazedoxifene Acetate)
	Affected / at Risk (%)	# Events
Total	95/3034 (3.1%)
Blood and lymphatic system disorders
Anaemia	2/3034 (0.1%)
Cardiac disorders
Acute myocardial infarction	1/3034 (0%)
Atrioventricular block complete	1/3034 (0%)
Cardiac failure	4/3034 (0.1%)
Cardiac failure acute	4/3034 (0.1%)
Cardiac failure congestive	1/3034 (0%)
Cardiac failure chronic	1/3034 (0%)
Myocardial infarction	1/3034 (0%)
Gastrointestinal disorders
Anorectal disorder	1/3034 (0%)
Autoimmune pancreatitis	1/3034 (0%)
Colitis ischaemic	1/3034 (0%)
Gastric ulcer haemorrhage	1/3034 (0%)
Haematochezia	1/3034 (0%)
Intestinal obstruction	1/3034 (0%)
General disorders
Condition aggravated	2/3034 (0.1%)
Death	4/3034 (0.1%)
Disease progression	1/3034 (0%)
Hepatobiliary disorders
Bile duct obstruction	1/3034 (0%)
Cholecystitis acute	1/3034 (0%)
Cholelithiasis	1/3034 (0%)
Hepatic cirrhosis	1/3034 (0%)
Hepatic function abnormal	1/3034 (0%)
Infections and infestations
Biliary tract infection	1/3034 (0%)
Herpes zoster	1/3034 (0%)
Pneumonia	1/3034 (0%)
Pneumonia bacterial	1/3034 (0%)
Injury, poisoning and procedural complications
Bone contusion	1/3034 (0%)
Compression fracture	3/3034 (0.1%)
Fall	2/3034 (0.1%)
Femoral neck fracture	5/3034 (0.2%)
Femur fracture	5/3034 (0.2%)
Fracture	2/3034 (0.1%)
Heat illness	1/3034 (0%)
Humerus fracture	1/3034 (0%)
Lumbar vertebral fracture	5/3034 (0.2%)
Radius fracture	1/3034 (0%)
Subdural haematoma	1/3034 (0%)
Thoracic vertebral fracture	2/3034 (0.1%)
Investigations
Haemoglobin decreased	1/3034 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/3034 (0%)
Dehydration	1/3034 (0%)
Diabetes mellitus	1/3034 (0%)
Marasmus	1/3034 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/3034 (0%)
Intervertebral disc protrusion	1/3034 (0%)
Osteoarthritis	3/3034 (0.1%)
Osteonecrosis	1/3034 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer	1/3034 (0%)
Brain neoplasm	1/3034 (0%)
Breast cancer	4/3034 (0.1%)
Colon cancer	8/3034 (0.3%)
Gallbladder cancer	1/3034 (0%)
Lung cancer metastatic	1/3034 (0%)
Lung neoplasm malignant	2/3034 (0.1%)
Metastases to liver	1/3034 (0%)
Myelodysplastic syndrome	1/3034 (0%)
Neoplasm recurrence	1/3034 (0%)
Ovarian cancer	2/3034 (0.1%)
Pancreatic carcinoma	2/3034 (0.1%)
Rectal cancer	1/3034 (0%)
Ureteric cancer	1/3034 (0%)
Nervous system disorders
Altered state of consciousness	1/3034 (0%)
Cerebellar infarction	1/3034 (0%)
Cerebral haemorrhage	1/3034 (0%)
Cerebral infarction	5/3034 (0.2%)
Hepatic encephalopathy	1/3034 (0%)
Subarachnoid haemorrhage	1/3034 (0%)
Renal and urinary disorders
Calculus ureteric	1/3034 (0%)
Renal failure	1/3034 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	4/3034 (0.1%)
Interstitial lung disease	1/3034 (0%)
Respiratory failure	1/3034 (0%)
Pulmonary oedema	2/3034 (0.1%)
Vascular disorders
Aortic dissection	1/3034 (0%)
Peripheral arterial occlusive disease	1/3034 (0%)
Other (Not Including Serious) Adverse Events
	Viviant (Bazedoxifene Acetate)
	Affected / at Risk (%)	# Events
Total	83/3034 (2.7%)
Musculoskeletal and connective tissue disorders
Back pain	25/3034 (0.8%)
Lumbar spinal stenosis	18/3034 (0.6%)
Osteoarthritis	20/3034 (0.7%)
Spinal osteoarthritis	20/3034 (0.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.