Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01416194
First received: August 11, 2011
Last updated: August 12, 2014
Last verified: August 2014

August 11, 2011
August 12, 2014
July 2011
August 2015   (final data collection date for primary outcome measure)
Incidence of venous thromboembolism (VTE) [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01416194 on ClinicalTrials.gov Archive Site
  • Incidence of ischemic stroke [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of thrombotic cardiac disorders [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of atrial fibrillation [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of biliary events [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of hypertriglyceridemia [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of fracture [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of chronic renal failure [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of malignancies [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of depression [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of ischemic cardiac disorders [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of acute renal failure [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Selected ocular events including retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. [ Time Frame: During up to 5 years ] [ Designated as safety issue: Yes ]
  • Goiter [ Time Frame: During up to 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of ischemic stroke [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of thrombotic and ischemic cardiac disorders [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of atrial fibrillation [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of biliary events [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of hypertriglyceridemia [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of fracture [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of chronic and acute renal failure [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of malignancies [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
  • Incidence of depression [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
Cohort Study Of Venous Thromboembolism And Other Clinical Endpoints Among Osteoporotic Women Prescribed Bazedoxifene, Bisphosphonates Or Raloxifene In Europe

This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups.

All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Women aged 45 or over who have records of receiving bazedoxifene, bisphosphonates or raloxifene in the Cegedim database in Italy and Spain.

Osteoporosis, Postmenopausal
  • Drug: Bazedoxifene
    Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
  • Drug: Bisphosphonate
    Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
  • Drug: Raloxifene
    Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
  • Bazedoxifene
    Intervention: Drug: Bazedoxifene
  • Primary Comparator
    Intervention: Drug: Bisphosphonate
  • Secondary Comparator
    Intervention: Drug: Raloxifene
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10750
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female
  • At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);
  • A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;
  • Age >=45 at the date of the index prescription; and
  • At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription

Exclusion Criteria:

  • There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01416194
B1781044
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP