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Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women


Phase 3
55 Years
80 Years
Not Enrolling
Female
Osteoporosis

Thank you

Trial Information

Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women


Inclusion Criteria:



- Must be at least 2 years postmenopausal

- Osteoporotic subjects without vertebral fracture who meet BMD criteria, or
Osteoporotic subjects with vertebral fracture

Exclusion Criteria:

- Diseases that may affect bone metabolism

- Vasomotor symptoms requiring treatment

- Known history or suspected cancer of the breast

- Active or past history of venous thromboembolic events

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With New Vertebral Fractures Through Month 36

Outcome Description:

New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.

Outcome Time Frame:

Baseline through Month 36

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3068A1-301

NCT ID:

NCT00205777

Start Date:

December 2001

Completion Date:

September 2010

Related Keywords:

  • Osteoporosis
  • Osteoporosis
  • Postmenopause
  • Osteoporosis

Name

Location

Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Las Vegas, Nevada  89128
Pfizer Investigational Site Santa Fe, New Mexico  87505
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Easley,, South Carolina  29640
Pfizer Investigational Site Farmington, Connecticut  06030-3805
Pfizer Investigational Site Milwaukee, Wisconsin  53215
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654
Pfizer Investigational Site Livingston, New Jersey  07039
Pfizer Investigational Site Washington, District of Columbia  20007-2197
Pfizer Investigational Site Salt Lake City, Utah  84112
Pfizer Investigational Site Billings, Montana  59101
Pfizer Investigational Site Lewistown, Idaho  83501
Pfizer Investigational Site Bangor, Maine  04401
Pfizer Investigational Site Newark, Delaware  19713
Pfizer Investigational Site Bismarck, North Dakota  58503
Pfizer Investigational Site Aberdeen, South Dakota  57401
Pfizer Investigational Site Cheyenne, Wyoming  82001