Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL) (PEARL)

August 8, 2011 updated by: Ligand Pharmaceuticals

PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

8556

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal, Argentina, C1115AAJ
        • Pfizer Investigational Site
      • Capital Federal, Argentina, C1428AQK
        • Pfizer Investigational Site
      • Capital Federal - Buenos Aires, Argentina, C1012AAP
        • Pfizer Investigational Site
      • S2000DHL- Rosario - Santa Fe, Argentina
        • Pfizer Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1114AAH
        • Pfizer Investigational Site
      • Capital Federal, Buenos Aires, Argentina, C1117ABH
        • Pfizer Investigational Site
    • Capital Federal
      • Buenos Aires, Capital Federal, Argentina, C1287ACF
        • Pfizer Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000 DHL
        • Pfizer Investigational Site
      • Rosario, Santa Fe, Argentina, S2000DHL
        • Pfizer Investigational Site
  • Australia
      • Randwick, Australia, NSW 2031
        • Pfizer Investigational Site
    • New South Wales
      • Concord, New South Wales, Australia, NSW 2139
        • Pfizer Investigational Site
      • Randwick, New South Wales, Australia, 2031
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5006
        • Pfizer Investigational Site
      • Ashford, South Australia, Australia, 5035
        • Pfizer Investigational Site
      • Dulwich, South Australia, Australia, 5065
        • Pfizer Investigational Site
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Pfizer Investigational Site
      • Heidelberg, Victoria, Australia, 3081
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, WA 6009
        • Pfizer Investigational Site
  • Belgium
      • Genk, Belgium, 3590
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04013002
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 04062-003
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 04230-000
        • Pfizer Investigational Site
      • São Caetano do Sul, SP, Brazil, 09540-830
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Pfizer Investigational Site
      • Calgary, Alberta, Canada, T2N 2T9
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3A6
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 3Y1
        • Pfizer Investigational Site
      • Vancouver, British Columbia, Canada, V6H 3X8
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Pfizer Investigational Site
      • Hamilton, Ontario, Canada, L8N 2B6
        • Pfizer Investigational Site
      • Hamilton, Ontario, Canada, L8N 4A6
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 1P1
        • Pfizer Investigational Site
      • Montréal, Quebec, Canada, H5B 1B2
        • Pfizer Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 3M7
        • Pfizer Investigational Site
      • Sainte-foy, Quebec, Canada, G1V 4G2
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Pfizer Investigational Site
  • Costa Rica
      • Cartago, Costa Rica
        • Pfizer Investigational Site
      • Escazu, Costa Rica
        • Pfizer Investigational Site
      • San Jose, Costa Rica
        • Pfizer Investigational Site
    • San Jose
      • Curridabat, San Jose, Costa Rica
        • Pfizer Investigational Site
      • Paseo Colon, San Jose, Costa Rica
        • Pfizer Investigational Site
      • San Pedro, San Jose, Costa Rica
        • Pfizer Investigational Site
  • Croatia
      • Zagreb, Croatia, 10000
        • Pfizer Investigational Site
      • Zagreb, Croatia, 10.000
        • Pfizer Investigational Site
  • Denmark
      • Aarhus C, Denmark, 8000
        • Pfizer Investigational Site
      • Hvidovre, Denmark, DK-2650
        • Pfizer Investigational Site
  • Egypt
      • Cairo, Egypt
        • Pfizer Investigational Site
      • Heliopolis, Cairo, Egypt
        • Pfizer Investigational Site
  • Estonia
      • Parnu, Estonia, 80010
        • Pfizer Investigational Site
      • Tallin, Estonia, 11312
        • Pfizer Investigational Site
      • Tallin, Estonia, 13419
        • Pfizer Investigational Site
      • Tallinn, Estonia, 10138
        • Pfizer Investigational Site
      • Tartu, Estonia, 50410
        • Pfizer Investigational Site
  • Finland
      • Helsinki, Finland, FIN-00100
        • Pfizer Investigational Site
      • Oulu, Finland, FIN-90100
        • Pfizer Investigational Site
      • Turku, Finland, 20100
        • Pfizer Investigational Site
  • France
      • Lyon, France, 69003
        • Pfizer Investigational Site
      • Lyon Cedex 03, France, 69437
        • Pfizer Investigational Site
      • Paris Cedex 14, France, 75674
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 12200
        • Pfizer Investigational Site
      • Berlin, Germany, 12203
        • Pfizer Investigational Site
      • Muenchen, Germany, 80809
        • Pfizer Investigational Site
  • Hong Kong
      • New Territories, Hong Kong
        • Pfizer Investigational Site
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, H-1082
        • Pfizer Investigational Site
      • Budapest, Hungary, H-1088
        • Pfizer Investigational Site
      • Debrecen, Hungary, H-4012
        • Pfizer Investigational Site
      • Gyor, Hungary, H-9023
        • Pfizer Investigational Site
      • Gyor, Hungary, H-9024
        • Pfizer Investigational Site
  • India
      • Jaipur, India, 302017
        • Pfizer Investigational Site
      • New Delhi, India, 110 029
        • Pfizer Investigational Site
      • Parel, Mumbai, India, 400 012
        • Pfizer Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 033
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560-054
        • Pfizer Investigational Site
    • Kerala
      • Thiruvananthapuram, Kerala, India, 695 011
        • Pfizer Investigational Site
    • Mumbai
      • Matunga (East), Mumbai, India
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Pfizer Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 014
        • Pfizer Investigational Site
      • Chennai, Tamil Nadu, India, 600 035
        • Pfizer Investigational Site
      • Vellore, Tamil Nadu, India, 632004
        • Pfizer Investigational Site
  • Ireland
      • Dublin, Ireland, 2
        • Pfizer Investigational Site
  • Italy
      • Firenze, Italy, 50134
        • Pfizer Investigational Site
      • Firenze, Italy, 50139
        • Pfizer Investigational Site
      • Verona, Italy, 37034
        • Pfizer Investigational Site
      • Verona, Italy, 37122
        • Pfizer Investigational Site
  • Japan
      • Ohita, Japan
        • Pfizer Investigational Site
      • Tokyo, Japan
        • Pfizer Investigational Site
    • Ohita-ken
      • 15-3-1 Maki Ohita-shi, Ohita-ken, Japan
        • Pfizer Investigational Site
    • Tokyo
      • 2-7-8 Yoyogi Shibuya-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Shinjuku-ku, Tokyo, Japan
        • Pfizer Investigational Site
  • Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of, 100-380
        • Pfizer Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Pfizer Investigational Site
      • Kaunas, Lithuania, LT-3007
        • Pfizer Investigational Site
      • Klaipeda, Lithuania, LT-92288
        • Pfizer Investigational Site
      • Vilnius, Lithuania, LT-2600
        • Pfizer Investigational Site
      • Vilnius, Lithuania, LT-01102
        • Pfizer Investigational Site
      • Vilnius, Lithuania, LT-10318
        • Pfizer Investigational Site
      • Vilnius, Lithuania, LT-2055
        • Pfizer Investigational Site
  • Mexico
    • DF
      • Mexico, DF, Mexico, 14050
        • Pfizer Investigational Site
    • Mexico City
      • Tlalpan, Mexico City, Mexico, 14000
        • Pfizer Investigational Site
    • Mexico Df
      • Cp 11800, Mexico Df, Mexico
        • Pfizer Investigational Site
  • Norway
      • Bergen, Norway, 5012
        • Pfizer Investigational Site
      • Hamar, Norway, 2317
        • Pfizer Investigational Site
      • Hamar, Norway, 2300
        • Pfizer Investigational Site
      • Hamar, Norway, 2318
        • Pfizer Investigational Site
      • Oslo, Norway, 0164
        • Pfizer Investigational Site
      • Oslo, Norway, 0176
        • Pfizer Investigational Site
      • Paradis, Norway, 5231
        • Pfizer Investigational Site
  • Poland
      • Krakow, Poland, 31-501
        • Pfizer Investigational Site
      • Krakow, Poland, 30-315
        • Pfizer Investigational Site
      • Kraków, Poland, 31-501
        • Pfizer Investigational Site
      • Warsaw, Poland, 00-416
        • Pfizer Investigational Site
      • Warsaw, Poland, 00-719
        • Pfizer Investigational Site
      • Warsaw, Poland, 02-380
        • Pfizer Investigational Site
      • Warsaw, Poland, 02-634
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-416
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-341
        • Pfizer Investigational Site
    • Warszawa
      • Nowogrodzka 62A, Warszawa, Poland, 02-002
        • Pfizer Investigational Site
  • Romania
      • Bucharest, Romania, 70231
        • Pfizer Investigational Site
      • Bucharest, Romania
        • Pfizer Investigational Site
      • Bucuresti, Romania, 762511
        • Pfizer Investigational Site
      • Iasi, Romania, 6600
        • Pfizer Investigational Site
      • Timisoara, Romania
        • Pfizer Investigational Site
    • Timis
      • Timisoara, Timis, Romania, 1900
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Pfizer Investigational Site
      • Moscow, Russian Federation
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 115522
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 101953
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 117036
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 117815
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 190008
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 199034
        • Pfizer Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9300
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7500
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7129
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 2196
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 411 32
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06590
        • Pfizer Investigational Site
      • Izmir, Turkey
        • Pfizer Investigational Site
      • Izmir, Turkey, 35100
        • Pfizer Investigational Site
  • United Kingdom
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Pfizer Investigational Site
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • Pfizer Investigational Site
      • Harrow, Middlesex, United Kingdom, HA1 3RX
        • Pfizer Investigational Site
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Pfizer Investigational Site
      • Stanmore, Middlesex, United Kingdom, HA7 4LP
        • Pfizer Investigational Site
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 1LD
        • Pfizer Investigational Site
      • Aberdeen, Scotland, United Kingdom, AB25 2ZD
        • Pfizer Investigational Site
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35216
        • Pfizer Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92093-0659
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92161
        • Pfizer Investigational Site
      • Palm Desert, California, United States, 92260
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92262
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92263
        • Pfizer Investigational Site
      • Poway, California, United States, 94064
        • Pfizer Investigational Site
      • Rancho Mirage, California, United States, 92270
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
    • Florida
      • Brandon, Florida, United States, 33611
        • Pfizer Investigational Site
      • Leesburg, Florida, United States, 34748
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33613
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33607
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33414
        • Pfizer Investigational Site
    • Illinois
      • Des Plaines, Illinois, United States, 60016
        • Pfizer Investigational Site
      • Morton Grove, Illinois, United States, 60053
        • Pfizer Investigational Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Pfizer Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Pfizer Investigational Site
      • Montgomery Village, Maryland, United States, 20886
        • Pfizer Investigational Site
    • Minnesota
      • Arden Hills, Minnesota, United States, 55112
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55415-1226
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87106
        • Pfizer Investigational Site
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45409
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • Pennsylvania
      • Charleroia, Pennsylvania, United States, 15022
        • Pfizer Investigational Site
      • Monessen, Pennsylvania, United States, 15062
        • Pfizer Investigational Site
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23229
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23235
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23227
        • Pfizer Investigational Site
    • Washington
      • Redmond, Washington, United States, 98052
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98195
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98133
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98101-1448
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98105-4631
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98112
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: placebo
placebo
Experimental: lasofoxifene 0.5 mg/day
Drug: lasofoxifene
0.5 mg once per day, orally
Drug: lasofoxifene
0.25 mg once per day, orally
Experimental: lasofoxifene 0.25 mg/day
Drug: lasofoxifene
0.5 mg once per day, orally
Drug: lasofoxifene
0.25 mg once per day, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New morphometric vertebral fractures
Time Frame: 3 years
3 years
New cases of breast cancer
Time Frame: 5 years
5 years
New non-vertebral fractures
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
Time Frame: 3 years
3 years
All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ligand Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

August 15, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2181002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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