Clinical trial NCT00141323: Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
Official title: PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Ligand Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 8556
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: New morphometric vertebral fractures
timeFrame: 3 years
measure: New cases of breast cancer
timeFrame: 5 years
measure: New non-vertebral fractures
timeFrame: 5 years
Secondary outcomes:
measure: All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
timeFrame: 3 years
measure: All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Desert
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Poway
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Brandon
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Des Plaines
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Morton Grove
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Montgomery Village
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Arden Hills
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Centerville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Charleroia
country: United States
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state: Pennsylvania
city: Monessen
country: United States
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state: Pennsylvania
city: Cordova
country: United States
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state: Tennessee
city: Memphis
country: United States
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state: Tennessee
city: Dallas
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Richmond
country: United States
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state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Richmond
country: United States
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state: Virginia
city: Redmond
country: United States
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state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Seattle
country: United States
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state: Washington
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fe
city: Capital Federal - Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
city: S2000DHL- Rosario - Santa Fe
country: Argentina
facility: Pfizer Investigational Site
city: Concord
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Randwick
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Ashford
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Dulwich
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Geelong
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Randwick
country: Australia
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Caetano do Sul
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
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state: Quebec
city: Montréal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Pfizer Investigational Site
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city: Sainte-foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Curridabat
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Paseo Colon
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: San Pedro
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Cartago
country: Costa Rica
facility: Pfizer Investigational Site
city: Escazu
country: Costa Rica
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city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Aarhus C
country: Denmark
facility: Pfizer Investigational Site
city: Hvidovre
country: Denmark
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city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Heliopolis, Cairo
country: Egypt
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city: Parnu
country: Estonia
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tallin
country: Estonia
facility: Pfizer Investigational Site
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country: Estonia
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country: Estonia
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Oulu
country: Finland
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city: Turku
country: Finland
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city: Lyon Cedex 03
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 14
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
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city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
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city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
state: New Territories
city: New Territories
country: Hong Kong
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Gyor
country: Hungary
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city: Gyor
country: Hungary
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city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Thiruvananthapuram
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Matunga (East)
country: India
facility: Pfizer Investigational Site
state: Mumbai
city: Jaipur
country: India
facility: Pfizer Investigational Site
state: Rajasthan
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Vellore
country: India
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state: Tamil Nadu
city: Jaipur
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Parel, Mumbai
country: India
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
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city: Firenze
country: Italy
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country: Italy
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city: Verona
country: Italy
facility: Pfizer Investigational Site
city: Verona
country: Italy
facility: Pfizer Investigational Site
city: 15-3-1 Maki Ohita-shi
country: Japan
facility: Pfizer Investigational Site
state: Ohita-ken
city: 2-7-8 Yoyogi Shibuya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
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state: Tokyo
city: Ohita
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
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city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Korea
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country: Lithuania
facility: Pfizer Investigational Site
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country: Lithuania
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city: Klaipeda
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
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city: Vilnius
country: Lithuania
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city: Vilnius
country: Lithuania
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city: Vilnius
country: Lithuania
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city: Mexico
country: Mexico
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state: DF
city: Tlalpan
country: Mexico
facility: Pfizer Investigational Site
state: Mexico City
city: Cp 11800
country: Mexico
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state: Mexico Df
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Hamar
country: Norway
facility: Pfizer Investigational Site
city: Hamar
country: Norway
facility: Pfizer Investigational Site
city: Hamar
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Paradis
country: Norway
facility: Pfizer Investigational Site
city: Nowogrodzka 62A
country: Poland
facility: Pfizer Investigational Site
state: Warszawa
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Kraków
country: Poland
facility: Pfizer Investigational Site
city: Warsaw
country: Poland
facility: Pfizer Investigational Site
city: Warsaw
country: Poland
facility: Pfizer Investigational Site
city: Warsaw
country: Poland
facility: Pfizer Investigational Site
city: Warsaw
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Timisoara
country: Romania
facility: Pfizer Investigational Site
state: Timis
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Iasi
country: Romania
facility: Pfizer Investigational Site
city: Timisoara
country: Romania
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Harrow
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Harrow
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Northwood
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Stanmore
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Aberdeen
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Aberdeen
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Aberdeen
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Northwood, Middlesex
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ensrud K, LaCroix A, Thompson JR, Thompson DD, Eastell R, Reid DM, Vukicevic S, Cauley J, Barrett-Connor E, Armstrong R, Welty F, Cummings S. Lasofoxifene and cardiovascular events in postmenopausal women with osteoporosis: Five-year results from the Postmenopausal Evaluation and Risk Reduction with Lasofoxifene (PEARL) trial. Circulation. 2010 Oct 26;122(17):1716-24. doi: 10.1161/CIRCULATIONAHA.109.924571. Epub 2010 Oct 11.
citation: Cummings SR, Ensrud K, Delmas PD, LaCroix AZ, Vukicevic S, Reid DM, Goldstein S, Sriram U, Lee A, Thompson J, Armstrong RA, Thompson DD, Powles T, Zanchetta J, Kendler D, Neven P, Eastell R; PEARL Study Investigators. Lasofoxifene in postmenopausal women with osteoporosis. N Engl J Med. 2010 Feb 25;362(8):686-96. doi: 10.1056/NEJMoa0808692.