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: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Osteoporosis, Postmenopausal
Drug: Bazedoxifene
Drug: Bisphosphonate
Drug: Raloxifene
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cohort Study Of Venous Thromboembolism And Other Clinical Endpoints Among Osteoporotic Women Prescribed Bazedoxifene, Bisphosphonates Or Raloxifene In Europe

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of venous thromboembolism (VTE) [ Time Frame: During up to 5 years of follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10750
Study Start Date: July 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bazedoxifene Drug: Bazedoxifene
Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
Primary Comparator Drug: Bisphosphonate
Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
Secondary Comparator Drug: Raloxifene
Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416194

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01416194     History of Changes
Other Study ID Numbers: B1781044
Study First Received: August 11, 2011
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Venous Thromboembolism
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Diphosphonates
Raloxifene
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 23, 2014