Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss
NCT ID: NCT00925600
Last Updated: 2017-05-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
769 participants
INTERVENTIONAL
2009-11-30
2016-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Placebo
Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
Placebo
Prefilled syringe for subcutaneous (SC) injection
Denosumab
Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
Denosumab
Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg
Interventions
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Denosumab
Prefilled syringe for subcutaneous (SC) injection administered at a dose of 60 mg
Placebo
Prefilled syringe for subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate visual accuracy allowing eye testing
* Bone Mineral Density (BMD) requirements: Osteopenia if under 70 years of age; Osteopenia or normal BMD if over 70 years of age
* Signed informed consent
Exclusion Criteria
* Diagnosis of osteoporosis
30 Years
120 Years
MALE
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
Anaheim, California, United States
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Laguna Hills, California, United States
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Murrieta, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Luis Obispo, California, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Middlebury, Connecticut, United States
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New Britain, Connecticut, United States
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Trinity, Florida, United States
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Coeur d'Alene, Idaho, United States
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Greenwood, Indiana, United States
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West Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Shreveport, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Greenbelt, Maryland, United States
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Grand Rapids, Michigan, United States
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Sartell, Minnesota, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Berlin, New Jersey, United States
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Brick, New Jersey, United States
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Englewood, New Jersey, United States
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Lawrenceville, New Jersey, United States
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Mount Laurel, New Jersey, United States
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Albany, New York, United States
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Garden City, New York, United States
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Kingston, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Syracuse, New York, United States
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Gastonia, North Carolina, United States
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Greenville, North Carolina, United States
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Cincinnati, Ohio, United States
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Bala-Cynwyd, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Myrtle Beach, South Carolina, United States
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Knoxville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Richmond, Virginia, United States
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Salem, Virginia, United States
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Wahroonga, New South Wales, Australia
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Herston, Queensland, Australia
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Bentleigh East, Victoria, Australia
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Ringwood East, Victoria, Australia
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Brampton, Ontario, Canada
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Brantford, Ontario, Canada
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Burlington, Ontario, Canada
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Guelph, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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North Bay, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Benešov, , Czechia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Jindřichův Hradec, , Czechia
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Kroměříž, , Czechia
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Nový Jičín, , Czechia
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Olomouc, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Zlín, , Czechia
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Lyon Cédex 3, , France
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Paris, , France
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Alexandroupoli, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Heraklion, , Greece
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Larissa, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Baja, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Szeged, , Hungary
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Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Aurangabad, Maharashtra, India
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Nashik, Maharashtra, India
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Ludhiana, Punjab, India
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Madurai, Tamil Nadu, India
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Kolkata, West Bengal, India
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Jelgava, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Distrito Federal, , Mexico
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Distrito Federal, , Mexico
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Christchurch, , New Zealand
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Takapuna, North Shore City, , New Zealand
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Tauranga, , New Zealand
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Whangarei, , New Zealand
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Gdansk, , Poland
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Gdansk, , Poland
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Gdynia, , Poland
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Gdynia, , Poland
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Katowice, , Poland
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Mysłowice, , Poland
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Opole, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Siedlce, , Poland
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Szczecin, , Poland
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Słupsk, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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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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Nizhny Novgorod, , Russia
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Rostov-on-Don, , Russia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Košice, , Slovakia
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Košice, , Slovakia
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Martin, , Slovakia
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Nitra, , Slovakia
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Trenčín, , Slovakia
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Celje, , Slovenia
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Ljubljana, , Slovenia
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Slovenj Gradec, , Slovenia
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Paarl, Western Cape, South Africa
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George, , South Africa
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Kempton Park, , South Africa
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Port Elizabeth, , South Africa
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Tygerberg, , South Africa
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Chernivtsi, , Ukraine
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Dnipropetrovsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Uzhhorod, , Ukraine
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Zaporizhzhya, , Ukraine
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2009-012076-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20080560
Identifier Type: -
Identifier Source: org_study_id
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