Osteoporosis Clinical Trial
— PEARLOfficial title:
PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
| Verified date | August 2011 |
| Source | Ligand Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 8556 |
| Est. completion date | December 2007 |
| Est. primary completion date | December 2007 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 60 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | Capital Federal |
| Argentina | Pfizer Investigational Site | Capital Federal | Buenos Aires |
| Argentina | Pfizer Investigational Site | Capital Federal | Buenos Aires |
| Argentina | Pfizer Investigational Site | Capital Federal | |
| Argentina | Pfizer Investigational Site | Capital Federal | |
| Argentina | Pfizer Investigational Site | Capital Federal - Buenos Aires | |
| Argentina | Pfizer Investigational Site | Rosario | Santa Fe |
| Argentina | Pfizer Investigational Site | Rosario | Santa Fe |
| Argentina | Pfizer Investigational Site | S2000DHL- Rosario - Santa Fe | |
| Australia | Pfizer Investigational Site | Adelaide | South Australia |
| Australia | Pfizer Investigational Site | Ashford | South Australia |
| Australia | Pfizer Investigational Site | Concord | New South Wales |
| Australia | Pfizer Investigational Site | Dulwich | South Australia |
| Australia | Pfizer Investigational Site | Geelong | Victoria |
| Australia | Pfizer Investigational Site | Heidelberg | Victoria |
| Australia | Pfizer Investigational Site | Nedlands | Western Australia |
| Australia | Pfizer Investigational Site | Randwick | |
| Australia | Pfizer Investigational Site | Randwick | New South Wales |
| Belgium | Pfizer Investigational Site | Genk | |
| Belgium | Pfizer Investigational Site | Leuven | |
| Brazil | Pfizer Investigational Site | São Caetano do Sul | SP |
| Brazil | Pfizer Investigational Site | Sao Paulo | SP |
| Brazil | Pfizer Investigational Site | Sao Paulo | SP |
| Brazil | Pfizer Investigational Site | Sao Paulo | SP |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Calgary | Alberta |
| Canada | Pfizer Investigational Site | Hamilton | Ontario |
| Canada | Pfizer Investigational Site | Hamilton | Ontario |
| Canada | Pfizer Investigational Site | Hamilton | Ontario |
| Canada | Pfizer Investigational Site | Montreal | Quebec |
| Canada | Pfizer Investigational Site | Montréal | Quebec |
| Canada | Pfizer Investigational Site | Sainte-Foy | Quebec |
| Canada | Pfizer Investigational Site | Sainte-foy | Quebec |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Canada | Pfizer Investigational Site | Toronto | Ontario |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Canada | Pfizer Investigational Site | Vancouver | British Columbia |
| Canada | Pfizer Investigational Site | Winnipeg | Manitoba |
| Costa Rica | Pfizer Investigational Site | Cartago | |
| Costa Rica | Pfizer Investigational Site | Curridabat | San Jose |
| Costa Rica | Pfizer Investigational Site | Escazu | |
| Costa Rica | Pfizer Investigational Site | Paseo Colon | San Jose |
| Costa Rica | Pfizer Investigational Site | San Jose | |
| Costa Rica | Pfizer Investigational Site | San Pedro | San Jose |
| Croatia | Pfizer Investigational Site | Zagreb | |
| Croatia | Pfizer Investigational Site | Zagreb | |
| Denmark | Pfizer Investigational Site | Aarhus C | |
| Denmark | Pfizer Investigational Site | Hvidovre | |
| Egypt | Pfizer Investigational Site | Cairo | |
| Egypt | Pfizer Investigational Site | Heliopolis, Cairo | |
| Estonia | Pfizer Investigational Site | Parnu | |
| Estonia | Pfizer Investigational Site | Tallin | |
| Estonia | Pfizer Investigational Site | Tallin | |
| Estonia | Pfizer Investigational Site | Tallinn | |
| Estonia | Pfizer Investigational Site | Tartu | |
| Finland | Pfizer Investigational Site | Helsinki | |
| Finland | Pfizer Investigational Site | Oulu | |
| Finland | Pfizer Investigational Site | Turku | |
| France | Pfizer Investigational Site | Lyon | |
| France | Pfizer Investigational Site | Lyon Cedex 03 | |
| France | Pfizer Investigational Site | Paris Cedex 14 | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Muenchen | |
| Hong Kong | Pfizer Investigational Site | New Territories | |
| Hong Kong | Pfizer Investigational Site | Shatin | New Territories |
| Hungary | Pfizer Investigational Site | Budapest | |
| Hungary | Pfizer Investigational Site | Budapest | |
| Hungary | Pfizer Investigational Site | Debrecen | |
| Hungary | Pfizer Investigational Site | Gyor | |
| Hungary | Pfizer Investigational Site | Gyor | |
| India | Pfizer Investigational Site | Bangalore | Karnataka |
| India | Pfizer Investigational Site | Chennai | Tamil Nadu |
| India | Pfizer Investigational Site | Chennai | Tamil Nadu |
| India | Pfizer Investigational Site | Hyderabad | Andhra Pradesh |
| India | Pfizer Investigational Site | Jaipur | Rajasthan |
| India | Pfizer Investigational Site | Jaipur | |
| India | Pfizer Investigational Site | Matunga (East) | Mumbai |
| India | Pfizer Investigational Site | New Delhi | |
| India | Pfizer Investigational Site | Parel, Mumbai | |
| India | Pfizer Investigational Site | Thiruvananthapuram | Kerala |
| India | Pfizer Investigational Site | Vellore | Tamil Nadu |
| Ireland | Pfizer Investigational Site | Dublin | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Firenze | |
| Italy | Pfizer Investigational Site | Verona | |
| Italy | Pfizer Investigational Site | Verona | |
| Japan | Pfizer Investigational Site | 15-3-1 Maki Ohita-shi | Ohita-ken |
| Japan | Pfizer Investigational Site | 2-7-8 Yoyogi Shibuya-ku | Tokyo |
| Japan | Pfizer Investigational Site | Ohita | |
| Japan | Pfizer Investigational Site | Shinjuku-ku | Tokyo |
| Japan | Pfizer Investigational Site | Tokyo | |
| Korea, Republic of | Pfizer Investigational Site | Seoul | Korea |
| Lithuania | Pfizer Investigational Site | Kaunas | |
| Lithuania | Pfizer Investigational Site | Kaunas | |
| Lithuania | Pfizer Investigational Site | Klaipeda | |
| Lithuania | Pfizer Investigational Site | Vilnius | |
| Lithuania | Pfizer Investigational Site | Vilnius | |
| Lithuania | Pfizer Investigational Site | Vilnius | |
| Lithuania | Pfizer Investigational Site | Vilnius | |
| Mexico | Pfizer Investigational Site | Cp 11800 | Mexico Df |
| Mexico | Pfizer Investigational Site | Mexico | DF |
| Mexico | Pfizer Investigational Site | Tlalpan | Mexico City |
| Norway | Pfizer Investigational Site | Bergen | |
| Norway | Pfizer Investigational Site | Hamar | |
| Norway | Pfizer Investigational Site | Hamar | |
| Norway | Pfizer Investigational Site | Hamar | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Oslo | |
| Norway | Pfizer Investigational Site | Paradis | |
| Poland | Pfizer Investigational Site | Krakow | |
| Poland | Pfizer Investigational Site | Krakow | |
| Poland | Pfizer Investigational Site | Kraków | |
| Poland | Pfizer Investigational Site | Nowogrodzka 62A | Warszawa |
| Poland | Pfizer Investigational Site | Warsaw | |
| Poland | Pfizer Investigational Site | Warsaw | |
| Poland | Pfizer Investigational Site | Warsaw | |
| Poland | Pfizer Investigational Site | Warsaw | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Romania | Pfizer Investigational Site | Bucharest | |
| Romania | Pfizer Investigational Site | Bucharest | |
| Romania | Pfizer Investigational Site | Bucuresti | |
| Romania | Pfizer Investigational Site | Iasi | |
| Romania | Pfizer Investigational Site | Timisoara | |
| Romania | Pfizer Investigational Site | Timisoara | Timis |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| South Africa | Pfizer Investigational Site | Bloemfontein | |
| South Africa | Pfizer Investigational Site | Cape Town | |
| South Africa | Pfizer Investigational Site | Cape Town | |
| South Africa | Pfizer Investigational Site | Johannesburg | |
| Spain | Pfizer Investigational Site | Barcelona | |
| Spain | Pfizer Investigational Site | Madrid | |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Turkey | Pfizer Investigational Site | Ankara | |
| Turkey | Pfizer Investigational Site | Izmir | |
| Turkey | Pfizer Investigational Site | Izmir | |
| United Kingdom | Pfizer Investigational Site | Aberdeen | Scotland |
| United Kingdom | Pfizer Investigational Site | Aberdeen | Scotland |
| United Kingdom | Pfizer Investigational Site | Aberdeen | Scotland |
| United Kingdom | Pfizer Investigational Site | Harrow | Middlesex |
| United Kingdom | Pfizer Investigational Site | Harrow | Middlesex |
| United Kingdom | Pfizer Investigational Site | Northwood | Middlesex |
| United Kingdom | Pfizer Investigational Site | Northwood, Middlesex | |
| United Kingdom | Pfizer Investigational Site | Stanmore | Middlesex |
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Arden Hills | Minnesota |
| United States | Pfizer Investigational Site | Bethesda | Maryland |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Brandon | Florida |
| United States | Pfizer Investigational Site | Centerville | Ohio |
| United States | Pfizer Investigational Site | Charleroia | Pennsylvania |
| United States | Pfizer Investigational Site | Cordova | Tennessee |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Dayton | Ohio |
| United States | Pfizer Investigational Site | Des Moines | Iowa |
| United States | Pfizer Investigational Site | Des Plaines | Illinois |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | La Jolla | California |
| United States | Pfizer Investigational Site | Leesburg | Florida |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Monessen | Pennsylvania |
| United States | Pfizer Investigational Site | Montgomery Village | Maryland |
| United States | Pfizer Investigational Site | Morton Grove | Illinois |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Palm Desert | California |
| United States | Pfizer Investigational Site | Palm Springs | California |
| United States | Pfizer Investigational Site | Palm Springs | California |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Poway | California |
| United States | Pfizer Investigational Site | Rancho Mirage | California |
| United States | Pfizer Investigational Site | Redmond | Washington |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Ligand Pharmaceuticals |
United States, Argentina, Australia, Belgium, Brazil, Canada, Costa Rica, Croatia, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Norway, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | New morphometric vertebral fractures | 3 years | No | |
| Primary | New cases of breast cancer | 5 years | No | |
| Primary | New non-vertebral fractures | 5 years | No | |
| Secondary | All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events | 3 years | Yes | |
| Secondary | All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events | 5 years | Yes |
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