A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
NCT ID: NCT02186171
Last Updated: 2019-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
245 participants
INTERVENTIONAL
2014-06-16
2016-04-20
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
TREATMENT
TRIPLE
Study Groups
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Romosozumab
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Romosozumab
Administered by subcutaneous injection once a month.
Placebo
Participants received placebo subcutaneous injections once a month for 12 months.
Placebo
Administered by subcutaneous injection once a month.
Interventions
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Romosozumab
Administered by subcutaneous injection once a month.
Placebo
Administered by subcutaneous injection once a month.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.
Exclusion Criteria
* History of hip fracture
* Severe metabolic bone diseases
* Significant laboratory abnormalities
* Recent treatment with agents affecting bone metabolism
55 Years
90 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
Lakewood, Colorado, United States
Research Site
Bethesda, Maryland, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Genk, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Medellín, Antioquia, Colombia
Research Site
Bogota, Cundinamarca, Colombia
Research Site
Ostrava-Trebovice, , Czechia
Research Site
Pilsen, , Czechia
Research Site
Praha 11 - Chodov, , Czechia
Research Site
Aalborg, , Denmark
Research Site
Ballerup Municipality, , Denmark
Research Site
Mizunami-shi, Gifu, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Bungoono-shi, Oita Prefecture, Japan
Research Site
Takatsuki-shi, Osaka, Japan
Research Site
Hachioji-shi, Tokyo, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Research Site
Toshima-ku, Tokyo, Japan
Research Site
Mexicali, Baja California Norte, Mexico
Research Site
Monterrey, Nuevo León, Mexico
Research Site
Culiacán, Sinaloa, Mexico
Research Site
Lodz, , Poland
Research Site
Świdnik, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Bern, , Switzerland
Research Site
Zurich, , Switzerland
Research Site
Zurich, , Switzerland
Countries
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References
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Lewiecki EM, Blicharski T, Goemaere S, Lippuner K, Meisner PD, Miller PD, Miyauchi A, Maddox J, Chen L, Horlait S. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3183-3193. doi: 10.1210/jc.2017-02163.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-005551-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20110174
Identifier Type: -
Identifier Source: org_study_id
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