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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 SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteWashington, District of Columbia  20007-2197
Pfizer Investigational SiteSalt Lake City, Utah  84112
Pfizer Investigational SiteBillings, Montana  59101
Pfizer Investigational SiteLewistown, Idaho  83501
Pfizer Investigational SiteBangor, Maine  04401
Pfizer Investigational SiteNewark, Delaware  19713
Pfizer Investigational SiteBismarck, North Dakota  58503
Pfizer Investigational SiteAberdeen, South Dakota  57401
Pfizer Investigational SiteCheyenne, Wyoming  82001