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

NCT01470326 | Completed Results

• 1 other identifier: B1781007
• Study Type: observational
• Target: 3,187
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis

Keywords

Osteoporosis; Post menopausal women; SERM; Japanese; Viviant; Regulatory Post Marketing Commitment Plan; Long term treatment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 years

Secondary Outcomes (6)

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

  3 years

• Number of Participants With Treatment-Related Adverse Events by Age

  3 years

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

  3 years

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

  3 years

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

  3 years

Study Arms (1)

Bazedoxifene Tablets

Subjects taking Bazedoxifene Tablets

Drug: Bazedoxifene

Interventions

Bazedoxifene DRUG

For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.

Bazedoxifene Tablets

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets.

You may qualify if:

• Post menopausal women subjects with Osteoporosis who has no experience of use of Bazedoxifene.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Osteoporosis

Interventions

bazedoxifene

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 11, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-03