Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

NCT00141323 | Completed Phase 3 DMC

• 1 other identifier: A2181002
• Study Type: interventional
• Target: 8,556
• Locations: 31 countries
• Sites: 196

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (3)

• New morphometric vertebral fractures

  3 years

• New cases of breast cancer

  5 years

• New non-vertebral fractures

  5 years

Secondary Outcomes (2)

• All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events

  3 years

• All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events

  5 years

Study Arms (3)

lasofoxifene 0.5 mg/day

EXPERIMENTAL

Drug: lasofoxifene

placebo

PLACEBO COMPARATOR

Other: placebo

lasofoxifene 0.25 mg/day

EXPERIMENTAL

Drug: lasofoxifene

Interventions

lasofoxifene DRUG

0.5 mg once per day, orally

lasofoxifene 0.5 mg/day

placebo OTHER

placebo

placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ligand Pharmaceuticals: lead

Study Sites (201)

Pfizer Investigational Site

Birmingham, Alabama, 35205, United States

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Birmingham, Alabama, 35216, United States

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La Jolla, California, 92037, United States

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La Jolla, California, 92093-0659, United States

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La Jolla, California, 92161, United States

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Palm Desert, California, 92260, United States

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Palm Springs, California, 92262, United States

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Palm Springs, California, 92263, United States

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Poway, California, 94064, United States

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Rancho Mirage, California, 92270, United States

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San Diego, California, 92123, United States

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San Diego, California, 92128, United States

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Brandon, Florida, 33611, United States

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Leesburg, Florida, 34748, United States

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Tampa, Florida, 33607, United States

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Tampa, Florida, 33613, United States

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Tampa, Florida, 33614, United States

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West Palm Beach, Florida, 33414, United States

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Des Plaines, Illinois, 60016, United States

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Morton Grove, Illinois, 60053, United States

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Des Moines, Iowa, 50309, United States

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Bethesda, Maryland, 20817, United States

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Montgomery Village, Maryland, 20886, United States

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Arden Hills, Minnesota, 55112, United States

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Minneapolis, Minnesota, 55415-1226, United States

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Omaha, Nebraska, 68131, United States

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Albuquerque, New Mexico, 87102, United States

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Albuquerque, New Mexico, 87106, United States

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Centerville, Ohio, 45459, United States

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Dayton, Ohio, 45409, United States

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Portland, Oregon, 97239, United States

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Charleroia, Pennsylvania, 15022, United States

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Monessen, Pennsylvania, 15062, United States

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Cordova, Tennessee, 38018, United States

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Memphis, Tennessee, 38119, United States

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Dallas, Texas, 75230, United States

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San Antonio, Texas, 78229, United States

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Richmond, Virginia, 23225, United States

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Richmond, Virginia, 23227, United States

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Richmond, Virginia, 23229, United States

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Richmond, Virginia, 23235, United States

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Redmond, Washington, 98052, United States

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Seattle, Washington, 98101-1448, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98105-4631, United States

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Seattle, Washington, 98112, United States

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Seattle, Washington, 98133, United States

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Seattle, Washington, 98195, United States

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Capital Federal, Buenos Aires, C1114AAH, Argentina

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Capital Federal, Buenos Aires, C1117ABH, Argentina

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Buenos Aires, Buenos Aires F.D., C1287ACF, Argentina

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Rosario, Santa Fe Province, S2000 DHL, Argentina

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Rosario, Santa Fe Province, S2000DHL, Argentina

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Capital Federal - Buenos Aires, C1012AAP, Argentina

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Capital Federal, C1115AAJ, Argentina

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Capital Federal, C1428AQK, Argentina

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S2000dhl- Rosario - Santa Fe, Argentina

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Concord, New South Wales, NSW 2139, Australia

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Randwick, New South Wales, 2031, Australia

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Adelaide, South Australia, 5006, Australia

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Ashford, South Australia, 5035, Australia

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Dulwich, South Australia, 5065, Australia

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Geelong, Victoria, 3220, Australia

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Heidelberg, Victoria, 3081, Australia

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Nedlands, Western Australia, WA 6009, Australia

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Randwick, NSW 2031, Australia

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Genk, 3590, Belgium

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Leuven, 3000, Belgium

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São Caetano do Sul, São Paulo, 09540-830, Brazil

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São Paulo, São Paulo, 04013002, Brazil

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São Paulo, São Paulo, 04062-003, Brazil

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São Paulo, São Paulo, 04230-000, Brazil

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Calgary, Alberta, T2N 2T9, Canada

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Calgary, Alberta, T2N 4N1, Canada

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Vancouver, British Columbia, V5Z 3A6, Canada

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Vancouver, British Columbia, V5Z 3Y1, Canada

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Vancouver, British Columbia, V6H 3X8, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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Hamilton, Ontario, L8N 1Y2, Canada

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Hamilton, Ontario, L8N 2B6, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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Toronto, Ontario, M5C 2T2, Canada

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Montreal, Quebec, H2X 1P1, Canada

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Montreal, Quebec, H5B 1B2, Canada

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Sainte-Foy, Quebec, G1V 3M7, Canada

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Sainte-Foy, Quebec, G1V 4G2, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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Cartago, Cartago Province, Costa Rica

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Curridabat, Provincia de San José, Costa Rica

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Paseo Colon, Provincia de San José, Costa Rica

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San José, Provincia de San José, Costa Rica

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San Pedro, Provincia de San José, Costa Rica

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Escazú, Costa Rica

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San José, Costa Rica

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Zagreb, 10.000, Croatia

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Zagreb, 10000, Croatia

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Aarhus C, 8000, Denmark

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Hvidovre, DK-2650, Denmark

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Cairo, Egypt

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Heliopolis, Cairo, Egypt

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Pärnu, 80010, Estonia

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Tallinn, 10138, Estonia

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Tallinn, 11312, Estonia

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Tallinn, 13419, Estonia

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Tartu, 50410, Estonia

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Helsinki, FIN-00100, Finland

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Oulu, FIN-90100, Finland

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Turku, 20100, Finland

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Lyon, 69003, France

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Lyon, 69437, France

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Paris, 75674, France

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Berlin, 12200, Germany

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Berlin, 12203, Germany

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München, 80809, Germany

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New Territories, Hong Kong, Hong Kong

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Shatin, New Territories, Hong Kong

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Budapest, H-1082, Hungary

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Budapest, H-1088, Hungary

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Debrecen, H-4012, Hungary

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Győr, H-9023, Hungary

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Győr, H-9024, Hungary

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Hyderabad, Andhra Pradesh, 500 033, India

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Bangalore, Karnataka, 560-054, India

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Thiruvananthapuram, Kerala, 695 011, India

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Matunga (East), Mumbai, India

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Jaipur, Rajasthan, 302017, India

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Chennai, Tamil Nadu, 600 014, India

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Chennai, Tamil Nadu, 600 035, India

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Vellore, Tamil Nadu, 632004, India

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Jaipur, 302017, India

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New Delhi, 110 029, India

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Parel, Mumbai, 400 012, India

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Dublin, Dublin, 2, Ireland

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Dublin, 2, Ireland

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Florence, 50134, Italy

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Florence, 50139, Italy

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Verona, 37034, Italy

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Verona, 37122, Italy

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15-3-1 Maki Ohita-shi, Ohita-ken, Japan

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Ohita, Ohita, Japan

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2-7-8 Yoyogi Shibuya-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Tokyo, Japan

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Kaunas, LT-3007, Lithuania

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Kaunas, LT-50009, Lithuania

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Klaipėda, LT-92288, Lithuania

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Vilnius, LT-01102, Lithuania

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Vilnius, LT-10318, Lithuania

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Vilnius, LT-2055, Lithuania

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Vilnius, LT-2600, Lithuania

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Mexico City, Mexico City, 14050, Mexico

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Tlalpan, Mexico City, 14000, Mexico

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Cp 11800, Mexico Df, Mexico

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Bergen, 5012, Norway

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Hamar, 2300, Norway

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Hamar, 2317, Norway

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Hamar, 2318, Norway

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Oslo, 0164, Norway

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Oslo, 0176, Norway

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Paradis, 5231, Norway

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Nowogrodzka 62A, Warszawa, 02-002, Poland

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Krakow, 30-315, Poland

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Krakow, 31-501, Poland

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Warsaw, 00-416, Poland

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Warsaw, 00-719, Poland

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Warsaw, 02-341, Poland

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Warsaw, 02-380, Poland

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Warsaw, 02-634, Poland

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Timișoara, Timiș County, 1900, Romania

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Bucharest, 70231, Romania

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Bucharest, 762511, Romania

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Bucharest, Romania

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Iași, 6600, Romania

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Timișoara, Romania

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Moscow, 101953, Russia

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Moscow, 115478, Russia

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Moscow, 115522, Russia

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Moscow, 117036, Russia

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Moscow, 117815, Russia

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Moscow, Russia

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Saint Petersburg, 190008, Russia

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Saint Petersburg, 199034, Russia

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Bloemfontein, 9300, South Africa

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Cape Town, 7129, South Africa

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Cape Town, 7500, South Africa

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Johannesburg, 2196, South Africa

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Seoul, Korea, 100-380, South Korea

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Barcelona, Barcelona, 08025, Spain

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Madrid, Madrid, 28041, Spain

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Gothenburg, 411 32, Sweden

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Ankara, 06590, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Harrow, Middlesex, HA1 3RX, United Kingdom

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Harrow, Middlesex, HA1 3UJ, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Stanmore, Middlesex, HA7 4LP, United Kingdom

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Aberdeen, Scotland, AB25 1LD, United Kingdom

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Aberdeen, Scotland, AB25 2ZD, United Kingdom

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Aberdeen, Scotland, AB25 2ZN, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Related Publications (2)

• 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.

  PMID: 20937977 DERIVED

• 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.

  PMID: 20181970 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Osteoporosis

Interventions

Lasofoxifene

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: November 1, 2001
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 15, 2011

Record last verified: 2011-08

Locations

IN (11); CA (15); HU (5); NO (7); CR (2); FI (3); RO (6); FR (3); BR (4); CO (7); BE (2); IT (4); TU (3); DE (3); ES (2); GB (8); RU (8); DK (2); AR (9); HK (2); IE (2); ZA (4); KR (1); AU (9); EG (2); LI (7); ME (3); PL (8); SE (1); US (48); JP (5)