Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
NCT ID: NCT01631214
Last Updated: 2025-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4093 participants
INTERVENTIONAL
2012-05-04
2017-06-29
Brief Summary
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Detailed Description
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The primary analysis was performed when clinical fracture events had been confirmed in at least 330 participants and all the participants had completed the month 24 visit. The study was to continue in an event-driven manner until at least 440 participants experienced a nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral fractures at the primary analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Alendronate/Alendronate
Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
Alendronate
Alendronate 70 mg tablet taken once a week
Placebo to Romosozumab
Administered by subcutaneous injection once a month during the double-blind treatment phase.
Romosozumab/Alendronate
Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.
Romosozumab
Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.
Alendronate
Alendronate 70 mg tablet taken once a week
Placebo to Alendronate
Matching placebo tablet taken once a week during the double-blind treatment phase.
Interventions
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Romosozumab
Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.
Alendronate
Alendronate 70 mg tablet taken once a week
Placebo to Romosozumab
Administered by subcutaneous injection once a month during the double-blind treatment phase.
Placebo to Alendronate
Matching placebo tablet taken once a week during the double-blind treatment phase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:
* at least 1 moderate (semiquantitative grade \[SQ\]2) or severe (SQ3) vertebral fracture OR
* at least 2 mild (SQ1) vertebral fractures OR
* BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:
* at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
* a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.
Exclusion Criteria
* 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
55 Years
90 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Hamburg, , Germany
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Hanover, , Germany
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Heinsberg, , Germany
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Birmingham, Alabama, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Downey, California, United States
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Greenbrae, California, United States
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Los Angeles, California, United States
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South Lake Tahoe, California, United States
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Tustin, California, United States
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Walnut Creek, California, United States
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Lakewood, Colorado, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Stuart, Florida, United States
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West Palm Beach, Florida, United States
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Gainesville, Georgia, United States
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Maywood, Illinois, United States
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Quincy, Illinois, United States
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Indianapolis, Indiana, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Las Cruces, New Mexico, United States
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Great Neck, New York, United States
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Bismarck, North Dakota, United States
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Pittsburgh, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Richmond, Virginia, United States
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Port Angeles, Washington, United States
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Madison, Wisconsin, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, , Argentina
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Darlinghurst, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Randwick, New South Wales, Australia
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Box Hill, Victoria, Australia
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Geelong, Victoria, Australia
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Heidelberg West, Victoria, Australia
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Parkville, Victoria, Australia
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Graz, , Austria
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Linz, , Austria
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Vienna, , Austria
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Bruges, , Belgium
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Brussels, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Fortaleza, Ceará, Brazil
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Vitória, Espírito Santo, Brazil
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Brasília, Federal District, Brazil
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Kitchener, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Westmout, Quebec, Canada
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Santiago, , Chile
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, Colombia
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Bogota, Cundinamarca, Colombia
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Bogota, Cundinamarca, Colombia
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Klatovy, , Czechia
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Opava, , Czechia
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Ostrava-Trebovice, , Czechia
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Pardubice, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Zlín, , Czechia
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Aalborg, , Denmark
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Århus C, , Denmark
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Ballerup Municipality, , Denmark
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Glostrup Municipality, , Denmark
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Hvidovre, , Denmark
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Køge, , Denmark
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Odense, , Denmark
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Vejle, , Denmark
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Santo Domingo, Nacional, Dominican Republic
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Santo Domingo, Nacional, Dominican Republic
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Santiago de los Caballeros, Santiago Province, Dominican Republic
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Santo Domingo, , Dominican Republic
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Tallinn, , Estonia
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Tartu, , Estonia
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Helsinki, , Finland
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Jyväskylä, , Finland
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Kuopio, , Finland
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Turku, , Finland
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Bordeaux, , France
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Cahors, , France
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Lille, , France
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Lyon Cédex 3, , France
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Orléans, , France
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Saint-Priest-en-Jarez, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Berlin, , Germany
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Bonn, , Germany
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Dresden, , Germany
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Frankfurt am Main, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Hellersdorf, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Marburg, , Germany
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München, , Germany
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Würzburg, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Antigua Guatemala, Departamento de Sacatepéquez, Guatemala
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Guatemala City, , Guatemala
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Guatemala City, , Guatemala
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Guatemala City, , Guatemala
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Hong Kong, , Hong Kong
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New Territories, , Hong Kong
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Balatonfüred, , Hungary
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Kiskunhalas, , Hungary
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Kistarcsa, , Hungary
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Veszprém, , Hungary
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Zalaegerszeg, , Hungary
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Cork, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Bnei Brak, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Tel Aviv, , Israel
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Arenzano GE, , Italy
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Bologna, , Italy
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Catania, , Italy
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Florence, , Italy
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Milan, , Italy
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Pisa, , Italy
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Pisa, , Italy
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Roma, , Italy
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Siena, , Italy
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Torino, , Italy
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Verona, , Italy
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Verona, , Italy
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Liepāja, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Mexicali, Baja California Norte, Mexico
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Mexicalli, Baja California Norte, Mexico
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León, Guanajuato, Mexico
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León, Guanajuato, Mexico
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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Querétaro City, Querétaro, Mexico
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Ciudad Obregón, Sonora, Mexico
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Leiden, , Netherlands
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Rotterdam, , Netherlands
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Venlo, , Netherlands
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Christchurch, , New Zealand
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Grafton, Auckland, , New Zealand
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Elverum, , Norway
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Hamar, , Norway
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Oslo, , Norway
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Stavanger, , Norway
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Bialystok, , Poland
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Dabrowka Dopiewo, , Poland
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Elblag, , Poland
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Gdynia, , Poland
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Gliwice, , Poland
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Katowice, , Poland
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Kielce, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Świdnik, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
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Oradea, , Romania
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Târgu Mureş, , Romania
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Arkhangelsk, , Russia
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Ivanovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Petrozavodsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Kosice-Saca, , Slovakia
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Lučenec, , Slovakia
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Piešťany, , Slovakia
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Trenčín, , Slovakia
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Parow, Western Cape, South Africa
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Somerset West, Western Cape, South Africa
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Tygerberg, , South Africa
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Daegu, , South Korea
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Guri-si, , South Korea
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Gwangju, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon-si, Gyeonggi-do, , South Korea
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Granada, Andalusia, Spain
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Seville, Andalusia, Spain
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Santander, Cantabria, Spain
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Barcelona, Catalonia, Spain
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Sant Joan Despí, Catalonia, Spain
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A Coruña, Galicia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Linköping, , Sweden
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Mölndal, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Adana, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Cambridge, , United Kingdom
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Cardiff, , United Kingdom
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Chorley, , United Kingdom
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Edinburgh, , United Kingdom
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Glasgow, , United Kingdom
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Liverpool, , United Kingdom
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Manchester, , United Kingdom
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Northwood, , United Kingdom
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Norwich, , United Kingdom
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Reading, , United Kingdom
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Sheffield, , United Kingdom
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Sidcup, , United Kingdom
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Staffordshire, , United Kingdom
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Warwick, , United Kingdom
Countries
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References
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Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.
Lau EMC, Dinavahi R, Woo YC, Wu CH, Guan J, Maddox J, Tolman C, Yang W, Shin CS. Romosozumab or alendronate for fracture prevention in East Asian patients: a subanalysis of the phase III, randomized ARCH study. Osteoporos Int. 2020 Apr;31(4):677-685. doi: 10.1007/s00198-020-05324-0. Epub 2020 Feb 11.
Miller PD, Adachi JD, Albergaria BH, Cheung AM, Chines AA, Gielen E, Langdahl BL, Miyauchi A, Oates M, Reid IR, Santiago NR, Vanderkelen M, Wang Z, Yu Z. Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. J Bone Miner Res. 2022 Aug;37(8):1437-1445. doi: 10.1002/jbmr.4563. Epub 2022 May 20.
Brown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, Nogues X, Civitelli R, De Villiers T, Massari F, Zerbini CAF, Wang Z, Oates MK, Recknor C, Libanati C. Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial. J Bone Miner Res. 2021 Nov;36(11):2139-2152. doi: 10.1002/jbmr.4409. Epub 2021 Aug 10.
McClung MR, Betah D, Leder BZ, Kendler DL, Oates M, Timoshanko J, Wang Z. Romosozumab improves microarchitecture as assessed by tissue thickness-adjusted trabecular bone score in postmenopausal women with osteoporosis. J Bone Miner Res. 2025 Feb 2;40(2):193-200. doi: 10.1093/jbmr/zjae194.
Ferrari S, Betah D, Feldman RG, Langdahl BL, Oates M, Timoshanko J, Wang Z, Dhaliwal R. Romosozumab Improves Tissue Thickness-Adjusted Trabecular Bone Score in Women With Osteoporosis and Diabetes. J Clin Endocrinol Metab. 2025 Sep 16;110(10):2861-2868. doi: 10.1210/clinem/dgae862.
Lane J, Langdahl B, Stone M, Kurth A, Oates M, Timoshanko J, Wang Z, Libanati C, Cosman F. Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials. Osteoporos Int. 2024 Jul;35(7):1195-1204. doi: 10.1007/s00198-024-07049-w. Epub 2024 Apr 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2011-003142-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110142
Identifier Type: -
Identifier Source: org_study_id
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