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Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Sponsored by Amgen

Phase Quota
Phase 3

The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis

Study Start Date: May 2012

Estimated Completion Date: February 2018

Specialties: Obstetrics & Gynecology: Menopausal Medicine Rheumatology: Bone Metabolism,Clinical Pharmacology Orthopedics: Bone Metabolism,Clinical Pharmacology

Interventions

  • Drug: Romosozumab
  • Drug: AMG 785
  • Drug: Alendronate

Inclusion criteria

  • Ambulatory postmenopausal women with osteoporosis (defined as low bone mineral density) and at least one vertebral fracture

Exclusion criteria

  • History of metabolic or bone disease (except osteoporosis) Use of agents affecting bone metabolism Vitamin D insufficiency History of solid organ or bone marrow transplants Hyper- or hypocalcemia Hyper- or hypothyroidism Hyper- or hypoparathyroidism Possible signs of intolerance to Alendronate

Study Locations And Contact Information

  • Research Site, Tallinn
  • Research Site, Bucharest
  • Research Site, Aalborg
  • Research Site, Sheffield
  • Research Site, Sofia
  • Research Site, Plovdiv
  • Research Site, Budapest
  • Research Site, Warszawa
  • Research Site, Bologna
  • Research Site, Opava
  • Research Site, Birmingham
  • Research Site, Toronto Ontario
  • Research Site, Genk
  • Research Site, Edinburgh
  • Research Site, Norwich
  • Research Site, Cambridge
  • Research Site, Bucharest
  • Research Site, Bethesda Maryland
  • Research Site, Frankfurt am Main
  • Research Site, Leon Guanajuato
  • Research Site, Hamburg
  • Research Site, Saint Petersburg
  • Research Site, Arenzano GE
  • Research Site, Moscow
  • Research Site, Bogota Cundinamarca
  • Research Site, Port Angeles Washington
  • Research Site, Leipzig
  • Research Site, Petrozavodsk
  • Research Site, Istanbul
  • Research Site, St. Johns Newfoundland and Labrador
  • Research Site, Dabrowka Dopiewo
  • Research Site, Trencin
  • Research Site, Vitória Espírito Santo
  • Research Site, Guatemala
  • Research Site, Budapest
  • Research Site, Bethesda Maryland
  • Research Site, Gent
  • Research Site, Kuopio
  • Research Site, Izmir
  • Research Site, Stavanger
  • Research Site, Fort Lauderdale Florida
  • Research Site, Siena
  • Research Site, Budapest
  • Research Site, Targu Mures
  • Research Site, Hvidovre
  • Research Site, Sevilla Andalucía
  • Research Site, Suwon-si, Gyeonggi-do
  • Research Site, Hamburg
  • Research Site, Moscow
  • Research Site, Christchurch
  • Research Site, New Territories
  • Research Site, Queretaro Querétaro
  • Research Site, Catania
  • Research Site, Ciudad Autonoma de Buenos Aires Buenos Aires
  • Research Site, Christchurch
  • Research Site, Bialystok
  • Research Site, Gliwice
  • Research Site, Toronto Ontario
  • Research Site, Madrid
  • Research Site, Vilnius
  • Research Site, Elblag
  • Research Site, Ballerup
  • Research Site, Liverpool
  • Research Site, Poznan
  • Research Site, Athens
  • Research Site, Barranquilla Atlántico
  • Research Site, Thessaloniki
  • Research Site, Arkhangelsk
  • Research Site, Guri-si
  • Research Site, Jerusalem
  • Research Site, Richmond Virginia
  • Research Site, Bismarck North Dakota
  • Research Site, Pisa
  • Research Site, Würzburg
  • Research Site, Opava
  • Research Site, Geelong Victoria
  • Research Site, Yaroslavl
  • Research Site, Bonn
  • Research Site, Ivanovo
  • Research Site, Bucaramanga
  • Research Site, Glostrup
  • Research Site, Randwick New South Wales
  • Research Site, Ciudad Autonoma de Buenos Aires Buenos Aires
  • Research Site, Tustin California
  • Research Site, Santiago
  • Research Site, Taipei
  • Research Site, Boston Massachusetts
  • Research Site, Bucharest
  • Research Site, Piestany
  • Research Site, Milan
  • Research Site, Bruxelles
  • Research Site, Madrid
  • Research Site, Vejle
  • Research Site, Sant Joan Despi Cataluña
  • Research Site, Pisa
  • Research Site, Magdeburg
  • Research Site, Haifa
  • Research Site, Bogota Cundinamarca
  • Research Site, Turku
  • Research Site, Bratislava
  • Research Site, Phoenix Arizona
  • Research Site, Bratislava
  • Research Site, Chorley
  • Research Site, Jyväskylä
  • Research Site, Manchester
  • Research Site, Catania
  • Research Site, Istanbul
  • Research Site, Liepaja
  • Research Site, Recife Pernambuco
  • Research Site, Bialystok
  • Research Site, Santiago
  • Research Site, Taipei
  • Research Site, Pretoria Gauteng
  • Research Site, Plzen
  • Research Site, Cardiff
  • Research Site, Reading
  • Research Site, Guatemala
  • Research Site, Maywood Illinois
  • Research Site, Kistarcsa
  • Research Site, Veszprem
  • Research Site, Glostrup
  • Research Site, Saint Petersburg
  • Research Site, Brugge
  • Research Site, Istanbul
  • Research Site, Katowice
  • Research Site, Medellin Antioquia
  • Research Site, Kiskunhalas
  • Research Site, Banska Bystrica
  • Research Site, Barranquilla Atlántico
  • Research Site, Westmout Quebec
  • Research Site, Las Cruces New Mexico
  • Research Site, Curitiba Paraná
  • Research Site, Vejle
  • Research Site, Downey California
  • Research Site, Riga
  • Research Site, Piestany
  • Research Site, Fortaleza Ceará
  • Research Site, Seoul
  • Research Site, Athens
  • Research Site, Pretoria Gauteng
  • Research Site, Ã?rhus C
  • Research Site, Freiburg
  • Research Site, Venlo
  • Research Site, Northwood
  • Research Site, Lima
  • Research Site, Guatemala
  • Research Site, Cordoba Córdoba
  • Research Site, Bismarck North Dakota
  • Research Site, Koge
  • Research Site, Elblag
  • Research Site, Poznan
  • Research Site, Torun
  • Research Site, Jyväskylä
  • Research Site, Port Angeles Washington
  • Research Site, Kitchener Ontario
  • Research Site, Johannesburg Gauteng
  • Research Site, Klatovy
  • Research Site, Chorley
  • Research Site, Seoul
  • Research Site, Cahors Cedex
  • Research Site, Norwich
  • Research Site, Sofia
  • Research Site, Moscow
  • Research Site, Guatemala
  • Research Site, Thessaloniki
  • Research Site, São Paulo
  • Research Site, Tainan
  • Research Site, UmeÃ¥
  • Research Site, Würzburg
  • Research Site, Trencin
  • Research Site, Gdynia
  • Research Site, South Lake Tahoe California
  • Research Site, Jerusalem
  • Research Site, Kielce
  • Research Site, Hong Kong
  • Research Site, Plzen
  • Research Site, Mexicali Baja California Norte
  • Research Site, Montreal Quebec
  • Research Site, Kosice-Saca
  • Research Site, Elverum
  • Research Site, Edinburgh
  • Research Site, Stavanger
  • Research Site, Ivanovo
  • Research Site, Bruxelles
  • Research Site, Lodz
  • Research Site, Kraków
  • Research Site, Roma
  • Research Site, Zalaegerszeg
  • Research Site, Praha 2
  • Research Site, Mexico Distrito Federal
  • Research Site, Bratislava
  • Research Site, Incheon
  • Research Site, Guatemala
  • Research Site, Indianapolis Indiana
  • Research Site, Guatemala
  • Research Site, Orleans Cedex
  • Research Site, Warwick
  • Research Site, Northwood
  • Research Site, Heidelberg West Victoria
  • Research Site, Torino
  • Research Site, Lucenec
  • Research Site, Winnipeg Manitoba
  • Research Site, Orleans Cedex
  • Research Site, Vilnius
  • Research Site, Sofia
  • Research Site, Halifax Nova Scotia
  • Research Site, Santo Domingo Distrito Nacional
  • Research Site, Galway
  • Research Site, Guatemala
  • Research Site, Ciudad Autonoma de Buenos Aires Buenos Aires
  • Research Site, Guatemala
  • Research Site, Bratislava
  • Research Site, Quebec
  • Research Site, Sofia
  • Research Site, Pisa
  • Research Site, Warszawa
  • Research Site, Praha 3
  • Research Site, Firenze
  • Research Site, Quincy Illinois
  • Research Site, Ostrava-Trebovice
  • Research Site, Los Angeles California
  • Research Site, Bucuresti
  • Research Site, Kaposvar
  • Research Site, Saint Priest en Jarez
  • Research Site, Saint Priest en Jarez
  • Research Site, Linz
  • Research Site, Linköping
  • Research Site, Jerusalem
  • Research Site, Pardubice
  • Research Site, Freiburg
  • Research Site, Hamar
  • Research Site, Warszawa
  • Research Site, Pardubice
  • Research Site, München
  • Research Site, Aalborg
  • Research Site, Kosice-Saca
  • Research Site, Wroclaw
  • Research Site, Brugge
  • Research Site, Wroclaw
  • Research Site, Stuart Florida
  • Research Site, Kielce
  • Research Site, Swidnik
  • Research Site, Westmout Quebec
  • Research Site, Las Vegas Nevada
  • Research Site, Leon Guanajuato
  • Research Site, Incheon
  • Research Site, Rio de Janeiro
  • Research Site, Budapest
  • Research Site, Suwon-si, Gyeonggi-do
  • Research Site, Larissa
  • Research Site, Greenbrae California
  • Research Site, Wroclaw
  • Research Site, Cahors Cedex
  • Research Site, Koge
  • Research Site, São Paulo
  • Research Site, Cardiff
  • Research Site, Lakewood Colorado
  • Research Site, Ostrava-Trebovice
  • Research Site, Lima
  • Research Site, Swidnik
  • Research Site, Brasília Distrito Federal
  • Research Site, Boston Massachusetts
  • Research Site, Santo Domingo
  • Research Site, Hamar
  • Research Site, Tainan
  • Research Site, Warszawa
  • Research Site, West Palm Beach Florida
  • Research Site, Geelong Victoria
  • Research Site, Saint Petersburg
  • Research Site, Montreal Quebec
  • Research Site, Mexico Distrito Federal
  • Research Site, Guatemala
  • Research Site, Lodz
  • Research Site, Budapest
  • Research Site, Warwick
  • Research Site, Tartu
  • Research Site, Quilmes Buenos Aires
  • Research Site, Leon Guanajuato
  • Research Site, Queretaro Querétaro
  • Research Site, Toulouse Cedex 9
  • Research Site, Walnut Creek California
  • Research Site, Leon Guanajuato
  • Research Site, Praha 3
  • Research Site, Firenze
  • Research Site, Curitiba Paraná
  • Research Site, Bogota Cundinamarca
  • Research Site, Siena
  • Research Site, Cambridge
  • Research Site, Guri-si
  • Research Site, Warszawa
  • Research Site, Stuart Florida
  • Research Site, Bucuresti
  • Research Site, Gainesville Georgia
  • Research Site, Monterrey Nuevo León
  • Research Site, Tartu
  • Research Site, Athens
  • Research Site, Budapest
  • Research Site, Athens
  • Research Site, Stockholm
  • Research Site, Brno
  • Research Site, Moscow
  • Research Site, Detroit Michigan
  • Research Site, Bucharest
  • Research Site, Turku
  • Research Site, Santander Cantabria
  • Research Site, Helsinki
  • Research Site, Rotterdam
  • Research Site, Grafton, Auckland
  • Research Site, Magdeburg
  • Research Site, Oslo
  • Research Site, Dresden
  • Research Site, Debrecen
  • Research Site, Ballerup
  • Research Site, Indianapolis Indiana
  • Research Site, Poznan
  • Research Site, Kuopio
  • Research Site, Larissa
  • Research Site, Plovdiv
  • Research Site, Stockholm
  • Research Site, Gyor
  • Research Site, Marburg
  • Research Site, Berlin
  • Research Site, New Territories
  • Research Site, Graz
  • Research Site, Great Neck New York
  • Research Site, Lodz
  • Research Site, Athens
  • Research Site, Manchester
  • Research Site, Daegu
  • Research Site, Verona
  • Research Site, Sofia
  • Research Site, Riga
  • Research Site, Las Cruces New Mexico
  • Research Site, Marburg
  • Research Site, Kaposvar
  • Research Site, Grafton, Auckland
  • Research Site, Peoria Arizona
  • Research Site, Lyon Cédex 3
  • Research Site, A Coruña Galicia
  • Research Site, Katowice
  • Research Site, Kogarah New South Wales
  • Research Site, Gwangju
  • Research Site, Lodz
  • Research Site, Leipzig
  • Research Site, Mölndal
  • Research Site, Guatemala
  • Research Site, Moscow
  • Research Site, Wyomissing Pennsylvania
  • Research Site, Lima
  • Research Site, Leiden
  • Research Site, Yaroslavl
  • Research Site, Frankfurt am Main
  • Research Site, Santo Domingo Distrito Nacional
  • Research Site, Mar del Plata Buenos Aires
  • Research Site, Cork
  • Research Site, Santo Domingo Distrito Nacional
  • Research Site, Bucaramanga
  • Research Site, Sofia
  • Research Site, Dublin
  • Research Site, Uherske Hradiste
  • Research Site, Zalaegerszeg
  • Research Site, Montreal Quebec
  • Research Site, Guatemala
  • Research Site, Peoria Arizona
  • Research Site, Seoul
  • Research Site, Veszprem
  • Research Site, Uherske Hradiste
  • Research Site, Richmond Virginia
  • Research Site, Cordoba Córdoba
  • Research Site, Wien
  • Research Site, Bogota
  • Research Site, Leuven
  • Research Site, Granada Andalucía
  • Research Site, Sofia
  • Research Site, Madrid
  • Research Site, Roma
  • Research Site, Thessaloniki
  • Research Site, Scottsdale Arizona
  • Research Site, Lima
  • Research Site, Vandoeuvre les Nancy
  • Research Site, Mexicali Baja California Norte
  • Research Site, Glasgow
  • Research Site, Bucuresti
  • Research Site, Parow Western Cape
  • Research Site, Sidcup
  • Research Site, Santiago
  • Research Site, Gainesville Georgia
  • Research Site, Frankfurt am Main
  • Research Site, Ekaterinburg
  • Research Site, Hannover
  • Research Site, Bnei Brak
  • Research Site, Riga
  • Research Site, Warszawa
  • Research Site, Seoul
  • Research Site, Bogota Cundinamarca
  • Research Site, Wien
  • Research Site, Bucharest
  • Research Site, Ciudad Obregon Sonora
  • Research Site, Somerset West Western Cape
  • Research Site, Liepaja
  • Research Site, St. Johns Newfoundland and Labrador
  • Research Site, Bordeaux Cedex
  • Research Site, Dresden
  • Research Site, Gyor
  • Research Site, Ciudad Autonoma de Buenos Aires Buenos Aires
  • Research Site, Wroclaw
  • Research Site, Pittsburgh Pennsylvania
  • Research Site, Toulouse Cedex 9
  • Research Site, Hradec Kralove
  • Research Site, Oslo
  • Research Site, Sofia
  • Research Site, Kraków
  • Research Site, Parow Western Cape
  • Research Site, Staffordshire
  • Research Site, Vilnius
  • Research Site, Lakewood Colorado
  • Research Site, Athens
  • Research Site, Praha 2
  • Research Site, Madison Wisconsin
  • Research Site, Downey California
  • Research Site, Ciudad Autonoma de Buenos Aires Buenos Aires
  • Research Site, Montreal Quebec
  • Research Site, Bogota
  • Research Site, Tygerberg
  • Research Site, Arkhangelsk
  • Research Site, Mar del Plata Buenos Aires
  • Research Site, Arenzano GE
  • Research Site, Kistarcsa
  • Research Site, Bonn
  • Research Site, Lima
  • Research Site, Wroclaw
  • Research Site, West Palm Beach Florida
  • Research Site, Linz
  • Research Site, Reading
  • Research Site, Dublin
  • Research Site, Odense
  • Research Site, Hong Kong
  • Research Site, Oradea
  • Research Site, Sevilla Andalucía
  • Research Site, Pisa
  • Research Site, Bogota Cundinamarca
  • Research Site, Moscow
  • Research Site, Birmingham Alabama
  • Research Site, Sheffield
  • Research Site, Guatemala
  • Research Site, Petrozavodsk
  • Research Site, Vandoeuvre les Nancy
  • Research Site, Pretoria Gauteng
  • Research Site, Buenos Aires
  • Research Site, Moscow
  • Research Site, Izmir
  • Research Site, Guatemala
  • Research Site, Madison Wisconsin
  • Research Site, Mölndal
  • Research Site, Krakow
  • Research Site, Lille cedex
  • Research Site, Guatemala
  • Research Site, Liverpool
  • Research Site, Nizhniy Novgorod
  • Research Site, Nizhniy Novgorod
  • Research Site, Lyon Cédex 3
  • Research Site, Leuven
  • Research Site, Zlin
  • Research Site, Klatovy
  • Research Site, Bucuresti
  • Research Site, Athens
  • Research Site, Bekescsaba
  • Research Site, Fort Lauderdale Florida
  • Research Site, Gent
  • Research Site, Gliwice
  • Research Site, Elverum
  • Research Site, Bialystok
  • Research Site, Glasgow
  • Research Site, Tygerberg
  • Research Site, Buenos Aires
  • Research Site, Saint Petersburg
  • Research Site, Berlin (Hellersdorf)
  • Research Site, São Paulo
  • Research Site, Jerusalem
  • Research Site, Hvidovre
  • Research Site, Vitória Espírito Santo
  • Research Site, Verona
  • Research Site, Kogarah New South Wales
  • Research Site, St. Louis Missouri
  • Research Site, Rio de Janeiro
  • Research Site, Mexicalli Baja California Norte
  • Research Site, Targu Mures
  • Research Site, Heinsberg
  • Research Site, Milan
  • Research Site, Balatonfured
  • Research Site, Gdynia
  • Research Site, Odense
  • Research Site, Tel Aviv
  • Research Site, Lima
  • Research Site, Maywood Illinois
  • Research Site, Lucenec
  • Research Site, Miami Florida
  • Research Site, Sidcup
  • Research Site, Liège
  • Research Site, Birmingham
  • Research Site, Poznan
  • Research Site, Linköping
  • Research Site, Bnei Brak
  • Research Site, Seoul
  • Research Site, Gwangju
  • Research Site, Sofia
  • Research Site, Adana
  • Research Site, Istanbul
  • Research Site, Venlo
  • Research Site, Saint-Petersburg
  • Research Site, Guatemala
  • Research Site, Thessaloniki
  • Research Site, Wroclaw
  • Research Site, Leiden
  • Research Site, Heinsberg
  • Research Site, Darlinghurst New South Wales
  • Research Site, Sofia
  • Research Site, Verona
  • Research Site, Rotterdam
  • Research Site, Tallinn
  • Research Site, Debrecen
  • Research Site, Galway
  • Research Site, Great Neck New York
  • Research Site, Genk
  • Research Site, Bekescsaba
  • Research Site, Moscow
  • Research Site, Riga
  • Research Site, Balatonfured
  • Research Site, Banska Bystrica
  • Research Site, Krakow
  • Research Site, Dabrowka Dopiewo
  • Research Site, Box Hill Victoria
  • Research Site, Quebec
  • Research Site, Ã?rhus C
  • Research Site, Sofia
  • Research Site, Daegu
  • Research Site, Kiskunhalas
  • Research Site, Athens
  • Research Site, Staffordshire
  • Research Site, Torun
  • Research Site, Brasília Distrito Federal
  • Research Site, Torino
  • Research Site, Bucharest
  • Research Site, Hradec Kralove
  • Research Site, Berlin (Hellersdorf)
  • Research Site, Oradea
  • Research Site, Trois-Rivieres Quebec
  • Research Site, Guatemala
  • Research Site, Liège
  • Research Site, Parkville Victoria
  • Research Site, Goiania Goiás
  • Research Site, Athens
  • Research Site, Cork
  • Research Site, Zlin
  • Research Site, Bialystok
  • Research Site, Hannover
  • Research Site, Frankfurt am Main
  • Research Site, Sofia
  • Research Site, Box Hill Victoria
  • Research Site, Berlin
  • Research Site, Santo Domingo
  • Research Site, Thessaloniki
  • Research Site, Miami Florida
  • Research Site, Madrid
  • Research Site, Lille cedex
  • Research Site, Graz
  • Research Site, Antigua Sacatepéquez
  • Research Site, UmeÃ¥
  • Research Site, Goiania Goiás
  • Research Site, Darlinghurst New South Wales
  • Research Site, Santo Domingo Distrito Nacional
  • Research Site, Verona
  • Research Site, Vilnius
  • Research Site, Bordeaux Cedex
  • Research Site, Adana
  • Research Site, Seoul
  • Research Site, Barcelona Cataluña
  • Research Site, Haifa
  • Research Site, São Paulo
  • Research Site, A Coruña Galicia
  • Research Site, Recife Pernambuco
  • Research Site, München
  • Research Site, Thessaloniki
  • Research Site, Athens
  • Research Site, Ekaterinburg
  • Research Site, Brno
  • Research Site, Santiago
  • Research Site, Tel Aviv
  • Research Site, Bologna
  • Research Site, Saint-Petersburg
  • Research Site, Vancouver British Columbia
  • Research Site, Helsinki

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