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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01631214
First received: May 24, 2012
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Postmenopausal Women With Osteoporosis
Drug: Romosozumab
Drug: Alendronate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence of clinical fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ] [ Designated as safety issue: No ]
    Event driven

  • Incidence of new vertebral fracture [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of fracture [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent changes in DXA Bone Mineral Density from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of fracture [ Time Frame: From baseline until the date of first clinical fracture assessed (approximately 24 months) ] [ Designated as safety issue: No ]
    Event driven

  • Percent changes in DXA Bone Mineral Density from baseline to 24 months [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • Percent changes in DXA Bone Mineral Density from baseline to 36 months [ Time Frame: 36 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: May 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Romosozumab
Romosozumab sub-cutaneous injections and placebo alendronate (oral) for 12 months, followed by open-label alendronate (oral) for at least another 12 months (until end of study)
Drug: Romosozumab
Romosozumab sub-cutaneous injections and placebo alendronate (oral) for 12 months followed by open-label alendronate (oral) for at least another 12 months (until end of study)
Other Name: sclerostin anitbody
Active Comparator: Alendronate
Oral alendronate plus placebo AMG 785 sub-cutaneous injections for 12 months, followed by open-label alendronate (oral) for at least another 12 months (until end of study)
Drug: Alendronate
Oral alendronate and placebo AMG 785 sub-cutaneous injections for 12 months, followed by open-label alendronate, (oral) for at least another 12 months (until end of study)
Other Name: biophosphantes, Fosamax

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Postmenopausal women with osteoporosis at high risk for fracture defined as:

  1. a hip BMD T-score of ≤-2.5 SD and a vertebral fracture or
  2. a hip BMD T-score of ≤-2.0 SD and a recent hip fracture or two vertebral fractures.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631214

Contacts
Contact: Amgen Call Center 866-572-6436

  Hide Study Locations
Locations
United States, Alabama
Research Site Recruiting
Birmingham, Alabama, United States, 35294
United States, Arizona
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85037
Research Site Completed
Scottsdale, Arizona, United States, 85258
United States, California
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Downey, California, United States, 90242
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Greenbrae, California, United States, 94904
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Los Angeles, California, United States, 90057
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South Lake Tahoe, California, United States, 96150
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Tustin, California, United States, 92780
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Walnut Creek, California, United States, 94598
United States, Colorado
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Lakewood, Colorado, United States, 80227
United States, Florida
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Fort Lauderdale, Florida, United States, 33309
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Miami, Florida, United States, 33136
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Stuart, Florida, United States, 34996
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West Palm Beach, Florida, United States, 33409
United States, Georgia
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Gainesville, Georgia, United States, 30501
United States, Illinois
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Maywood, Illinois, United States, 60153
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Quincy, Illinois, United States, 62301
United States, Indiana
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Indianapolis, Indiana, United States, 46202
United States, Maryland
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Bethesda, Maryland, United States, 20817
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
United States, Michigan
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Detroit, Michigan, United States, 48236
United States, Missouri
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St. Louis, Missouri, United States, 63110
United States, Nevada
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Las Vegas, Nevada, United States, 89148
United States, New Mexico
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Las Cruces, New Mexico, United States, 88011
United States, New York
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Great Neck, New York, United States, 11021
United States, North Dakota
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Bismarck, North Dakota, United States, 58503
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
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Wyomissing, Pennsylvania, United States, 19610
United States, Virginia
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Richmond, Virginia, United States, 23233
United States, Washington
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Port Angeles, Washington, United States, 98362
Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1128AAF
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1114
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Mar del Plata, Buenos Aires, Argentina, B7600DHK
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Quilmes, Buenos Aires, Argentina, B1878DVB
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Cordoba, Córdoba, Argentina, X5000BNB
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Buenos Aires, Argentina, C1012AAR
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Buenos Aires, Argentina, C1430CKE
Australia, New South Wales
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Darlinghurst, New South Wales, Australia, 2010
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Kogarah, New South Wales, Australia, 2217
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Randwick, New South Wales, Australia, 2031
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Geelong, Victoria, Australia, 3220
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Heidelberg West, Victoria, Australia, 3081
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Parkville, Victoria, Australia, 3050
Austria
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Graz, Austria, 8036
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Linz, Austria, 4010
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Wien, Austria, 1060
Belgium
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Brugge, Belgium, 8000
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Bruxelles, Belgium, 1000
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Genk, Belgium, 3600
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
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Liège, Belgium, 4020
Brazil
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Fortaleza, Ceará, Brazil, 60115-282
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Brasília, Distrito Federal, Brazil, 71625-009
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Vitória, Espírito Santo, Brazil, 29055-450
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Goiania, Goiás, Brazil, 74070-040
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Curitiba, Paraná, Brazil, 80030-110
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Recife, Pernambuco, Brazil, 52020-010
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Rio de Janeiro, Brazil, 22271-100
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São Paulo, Brazil, 04266-010
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São Paulo, Brazil, 05437-010
Bulgaria
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Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1421
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1612
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Sofia, Bulgaria, 1504
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Sofia, Bulgaria, 1709
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Sofia, Bulgaria, 1202
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E1
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
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Kitchener, Ontario, Canada, N2M 1A1
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Toronto, Ontario, Canada, M5G 2C4
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Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H3T 1E2
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Trois-Rivieres, Quebec, Canada, G8Z 1Y2
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Westmout, Quebec, Canada, H3Z 1E5
Canada
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Quebec, Canada, G1V 3M7
Chile
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Santiago, Chile, 8350595
Colombia
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Medellin, Antioquia, Colombia
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Medellin, Antioquia, Colombia, 050021
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Barranquilla, Atlántico, Colombia, 08001000
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Bogota, Cundinamarca, Colombia
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Bogota, Cundinamarca, Colombia, 110221
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Bogota, Cundinamarca, Colombia, 11001000
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Bogota, Colombia, 11001000
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Bucaramanga, Colombia, 68003
Czech Republic
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Brno, Czech Republic, 602 00
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Hradec Kralove, Czech Republic, 500 05
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Klatovy, Czech Republic, 339 01
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Opava, Czech Republic, 746 01
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Ostrava-Trebovice, Czech Republic, 722 00
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Pardubice, Czech Republic, 530 02
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Plzen, Czech Republic, 305 99
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Praha 2, Czech Republic, 128 08
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Praha 3, Czech Republic, 130 00
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Uherske Hradiste, Czech Republic, 686 01
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Zlin, Czech Republic, 760 01
Denmark
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Aalborg, Denmark, 9000
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Ballerup, Denmark, 2750
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Glostrup, Denmark, 2600
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Hvidovre, Denmark, 2650
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Køge, Denmark, 4600
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Odense, Denmark, 5000
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Vejle, Denmark, 7100
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Århus C, Denmark, 8000
Dominican Republic
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Santo Domingo, Distrito Nacional, Dominican Republic, 10514
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Santo Domingo, Distrito Nacional, Dominican Republic, 10124
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Santo Domingo, Distrito Nacional, Dominican Republic, 10124
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Santiago, Dominican Republic, 51000
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Santo Domingo, Dominican Republic, 10605
Estonia
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Tallinn, Estonia, 10128
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Tartu, Estonia, 50410
Finland
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Helsinki, Finland, 00100
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Jyväskylä, Finland, 40100
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Kuopio, Finland, 70211
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Turku, Finland, 20100
France
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Bordeaux Cedex, France, 33076
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Cahors Cedex, France, 46005
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Lille cedex, France, 59037
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Lyon Cédex 3, France, 69437
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Orleans cedex 1, France, 45032
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Saint Priest en Jarez, France, 42270
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Toulouse Cedex 9, France, 31059
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Vandoeuvre les Nancy, France, 54511
Germany
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Berlin, Germany, 12200
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Berlin (Hellersdorf), Germany, 12627
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Bonn, Germany, 53105
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Dresden, Germany, 01307
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Frankfurt am Main, Germany, 60596
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Frankfurt am Main, Germany, 60528
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Freiburg, Germany, 79106
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Hamburg, Germany, 20354
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Hannover, Germany, 30167
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Heinsberg, Germany, 52525
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Leipzig, Germany, 04103
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Magdeburg, Germany, 39104
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Marburg, Germany, 35043
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München, Germany, 80336
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Würzburg, Germany, 97074
Greece
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Athens, Greece, 14561
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Athens, Greece, 11525
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Athens, Greece, 16673
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Athens, Greece, 11527
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Athens, Greece, 11526
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Larissa, Greece, 41110
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Thessaloniki, Greece, 54636
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Thessaloniki, Greece, 56403
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Thessaloniki, Greece, 56429
Guatemala
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Antigua, Sacatepéquez, Guatemala, 03001
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Guatemala, Guatemala, 01009
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Guatemala, Guatemala, 01014
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Guatemala, Guatemala, 01015
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Guatemala, Guatemala, 01012
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Guatemala, Guatemala, 01001
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Guatemala, Guatemala, 01009
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Guatemala, Guatemala, 01010
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Guatemala, Guatemala, 01010
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Guatemala, Guatemala, 01007
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Guatemala, Guatemala, 01052
Hong Kong
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Hong Kong, Hong Kong
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New Territories, Hong Kong
Hungary
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Bekescsaba, Hungary, 5600
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Budapest, Hungary, 1036
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Budapest, Hungary, 1083
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Budapest, Hungary, 1084
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Debrecen, Hungary, 4032
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Kiskunhalas, Hungary, 6400
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Veszprem, Hungary, 8200
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Zalaegerszeg, Hungary, 8900
Ireland
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Cork, Ireland
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Dublin, Ireland, 8
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Galway, Ireland
Israel
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Bnei Brak, Israel, 51108
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Haifa, Israel, 31096
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Jerusalem, Israel, 71713
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Jerusalem, Israel, 91007
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Tel Aviv, Israel, 61999
Italy
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Arenzano GE, Italy, 16011
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Bologna, Italy, 40138
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Catania, Italy, 95124
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Firenze, Italy, 50139
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Milan, Italy, 20145
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Pisa, Italy, 56126
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Roma, Italy, 00161
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Siena, Italy, 53100
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Torino, Italy, 10126
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Verona, Italy, 37126
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Verona, Italy, 37134
Latvia
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Liepaja, Latvia, 3401
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Riga, Latvia, 1011
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Riga, Latvia, 1012
Lithuania
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Vilnius, Lithuania, 09310
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Vilnius, Lithuania, 10323
Mexico
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Mexicali, Baja California Norte, Mexico, 21100
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Mexicalli, Baja California Sur, Mexico, 21200
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Mexico, Distrito Federal, Mexico, 06700
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Mexico, Distrito Federal, Mexico, 06100
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Leon, Guanajuato, Mexico, 37000
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Leon, Guanajuato, Mexico, 37520
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Monterrey, Nuevo León, Mexico, 64460
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Queretaro, Querétaro, Mexico, 76000
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Ciudad Obregon, Sonora, Mexico, 85000
Netherlands
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Leiden, Netherlands, 2333 ZA
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Rotterdam, Netherlands, 3015 CE
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Venlo, Netherlands, 5912 BL
New Zealand
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Christchurch, New Zealand, 8022
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Grafton, Auckland, New Zealand, 1023
Norway
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Elverum, Norway, 2408
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Hamar, Norway, 2317
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Oslo, Norway, 0050
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Stavanger, Norway, 4005
Peru
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Lima, Peru, Lima 27
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Lima, Peru, Lima 33
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Lima, Peru, Lima11
Poland
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Bialystok, Poland, 15-351
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Bialystok, Poland, 15-879
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Dabrowka Dopiewo, Poland, 62-069
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Elblag, Poland, 82-300
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Gdynia, Poland, 81-384
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Gliwice, Poland, 44-100
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Katowice, Poland, 40-040
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Kielce, Poland, 25-317
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Krakow, Poland, 30-510
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Kraków, Poland, 31-501
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Lodz, Poland, 09-245
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Lodz, Poland, 90-558
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Poznan, Poland, 60-356
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Poznan, Poland, 60-702
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Swidnik, Poland, 21-040
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Torun, Poland, 87-100
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Warszawa, Poland, 01-192
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Warszawa, Poland, 04-730
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Warszawa, Poland, 02-507
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Wroclaw, Poland, 53-224
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Wroclaw, Poland, 51-124
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Wroclaw, Poland, 50-088
Romania
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Bucharest, Romania, 030463
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Bucharest, Romania, 011863
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Bucharest, Romania, 011172
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Bucuresti, Romania, 011863
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Bucuresti, Romania, 020125
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Oradea, Romania, 410028
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Targu Mures, Romania, 540142
Russian Federation
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Arkhangelsk, Russian Federation, 163001
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Ekaterinburg, Russian Federation, 620102
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Ivanovo, Russian Federation, 153025
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Moscow, Russian Federation, 127299
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Moscow, Russian Federation, 115522
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Moscow, Russian Federation, 117036
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Moscow, Russian Federation, 101990
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Nizhniy Novgorod, Russian Federation, 603155
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Petrozavodsk, Russian Federation, 185019
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Saint Petersburg, Russian Federation, 194291
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Saint Petersburg, Russian Federation, 190103
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Saint-Petersburg, Russian Federation, 199034
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Yaroslavl, Russian Federation, 150003
Slovakia
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Banska Bystrica, Slovakia, 974 01
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Bratislava, Slovakia, 813 69
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Bratislava, Slovakia, 826 06
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Kosice-Saca, Slovakia, 040 15
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Lucenec, Slovakia, 984 01
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Piestany, Slovakia, 921 12
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Trencin, Slovakia, 911 01
South Africa
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Johannesburg, Gauteng, South Africa, 2196
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Pretoria, Gauteng, South Africa, 0184
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Pretoria, Gauteng, South Africa, 0181
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Parow, Western Cape, South Africa, 7500
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Somerset West, Western Cape, South Africa, 7130
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Tygerberg, South Africa, 7505
Spain
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Granada, Andalucía, Spain, 18012
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Sevilla, Andalucía, Spain, 41009
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Santander, Cantabria, Spain, 39008
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Barcelona, Cataluña, Spain, 08003
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Sant Joan Despi, Cataluña, Spain, 08970
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A Coruña, Galicia, Spain, 15006
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Madrid, Spain, 28046
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Madrid, Spain, 28006
Sweden
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Linköping, Sweden, 581 85
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Mölndal, Sweden, 431 80
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Stockholm, Sweden, 141 86
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Umeå, Sweden, 907 36
Turkey
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Adana, Turkey, 01330
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Istanbul, Turkey, 34093
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Istanbul, Turkey, 34890
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Izmir, Turkey, 35100
United Kingdom
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Birmingham, United Kingdom, B15 2SQ
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Cambridge, United Kingdom, CB2 0QQ
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Cardiff, United Kingdom, CF14 5GJ
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Chorley, United Kingdom, PR7 7NA
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Edinburgh, United Kingdom, EH4 2XU
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Glasgow, United Kingdom, G20 0SP
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Liverpool, United Kingdom, L22 0LG
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Manchester, United Kingdom, M15 6SX
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Northwood, United Kingdom, HA6 2RN
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Norwich, United Kingdom, NR4 7TJ
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Reading, United Kingdom, RG2 0FT
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Sheffield, United Kingdom, S5 7AU
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Sidcup, United Kingdom, DA14 6LT
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Staffordshire, United Kingdom, WS11 5XY
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Warwick, United Kingdom, CV34 5BW
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01631214     History of Changes
Other Study ID Numbers: 20110142, 2011-003142-41
Study First Received: May 24, 2012
Last Updated: July 30, 2014
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
Australia: Therapeutic Goods Administration
Austria: Bundesamt für Sicherheit im Gesundheitswesen (BASG) / AGES Medizinmarktaufsicht
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Agência Nacional de Vigilância Sanitária
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Chile: Instituto de Salud Pública
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: Sundhedsstyrelsen (Danish Health and Medicines Authority)
Dominican Republic: Ministerio de Salud Pública (MSP) Consejo Nacional de Bioética en Salud (CONABIOS)
Estonia: Ravimiamet (State Agency of Medicines)
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé ANSM
Germany: Paul-Ehrlich-Institut
Greece: EOF (National Organization for Medicines)
Guatemala: Ministerio de Salud Pública y Asistencia Social. Departamento de Regulación y Control de Productos Farmacéuticos y Afines
Hong Kong: Department of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines, Directorate General of National Institute of Pharmacy (GYEMSZI-OGYI)
Ireland: Irish Medicines Board (IMB)
Israel: Ministry of Health
Italy: AIFA
Latvia: Zāļu valsts aģentūra (Latvia State Agency of Medicine)
Lithuania: Valstybinė vaistų kontrolės tarnyba (State Medicines Control Agency of Lithuania)
Mexico: Secretaría de Salud. Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Netherlands: Centrale Commissie Mensgebonden Onderzoek
New Zealand: Medsafe
Norway: Statens Legemiddelverk (Norwegian Medicines Agency)
Peru: Instituto Nacional de Salud
Poland: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: The National Agency for Medicines and Medical Devices, The National Ethics Committee for the Clinical Trials on Medicine
Russia: The Ministry of Healthcare of the Russian Federation (Minzdrav)
Slovakia: Štátny ústav pre kontrolu liečiv (Slovak institute for drug control)
Spain: AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS (AEMPS)
South Africa: Medicines Control Council
Sweden: Läkemedelsverket (Medical Products Agency)
Turkey: The Republic of Turkey Ministry of Health, Turkish Drug and Medical Device Institution
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Amgen:
Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014