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PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene


Phase 3
60 Years
80 Years
Not Enrolling
Female
Osteoporosis

Thank you

Trial Information

PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene


Inclusion Criteria:



Postmenopausal at least 5 years; Screening bone mineral density more than or equal to 2.5
S.D.s below the mean for young adults at the lumbar spine or femoral neck.

Exclusion Criteria:

Metabolic bone disease other than osteoporosis; Taking approved medications for
osteoporosis; Have had a recent osteoporotic fracture (within 1 year) and/or have a bone
mineral density more than 4.5 S.D.s below the mean for young adults at the lumbar spine or
femoral neck.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

New morphometric vertebral fractures

Outcome Time Frame:

3 years

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:

A2181002

NCT ID:

NCT00141323

Start Date:

November 2001

Completion Date:

December 2007

Related Keywords:

  • Osteoporosis
  • Osteoporosis

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620