Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids
NCT ID: NCT01575873
Last Updated: 2018-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
795 participants
INTERVENTIONAL
2012-03-28
2017-06-29
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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Denosumab
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
Denosumab
Administered by subcutaneous injection once every 6 months
Placebo for risendronate
Administered orally once a day
Risendronate
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
Risendronate
Administered orally once a day
Placebo for denosumab
Administered by subcutaneous injection once every 6 months
Interventions
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Denosumab
Administered by subcutaneous injection once every 6 months
Placebo for risendronate
Administered orally once a day
Risendronate
Administered orally once a day
Placebo for denosumab
Administered by subcutaneous injection once every 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
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
Birmingham, Alabama, United States
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Sacramento, California, United States
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Lakewood, Colorado, United States
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Pembroke Pines, Florida, United States
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Gainesville, Georgia, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Indianapolis, Indiana, United States
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Bethesda, Maryland, United States
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Cumberland, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Fargo, North Dakota, United States
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Fargo, North Dakota, United States
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Mayfield, Ohio, United States
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Duncansville, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Beckley, West Virginia, 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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Buenos Aires, , Argentina
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Brussels, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Liège, , Belgium
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Wilrijk, , Belgium
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Vancouver, British Columbia, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Waterloo, 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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Saskatoon, Saskatchewan, Canada
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Barranquilla, Atlántico, Colombia
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Brno, , 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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Praha 11 - Chodov, , Czechia
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Uherské Hradiště, , 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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Vejle, , Denmark
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Lyon Cédex 3, , France
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Orléans, , France
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Vandœuvre-lès-Nancy, , France
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Bad Nauheim, , Germany
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Bad Reichenhall, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Hildesheim, , Germany
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Vogelsang-Gommern, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyula, , Hungary
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Szeged, , Hungary
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Szikszó, , Hungary
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León, Guanajuato, Mexico
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Mexico City, Mexico City, Mexico
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Morelia, Michoacán, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Amsterdam, , Netherlands
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Helmond, , Netherlands
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Utrecht, , Netherlands
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Bialystok, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Stalowa Wola, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , 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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Daegu, , South Korea
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Daejeon, , South Korea
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Gwangju, , South Korea
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Jinju, , 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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Barcelona, Catalonia, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
Countries
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References
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Saag KG, Wagman RB, Geusens P, Adachi JD, Messina OD, Emkey R, Chapurlat R, Wang A, Pannacciulli N, Lems WF. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):445-454. doi: 10.1016/S2213-8587(18)30075-5. Epub 2018 Apr 6.
Saag KG, Pannacciulli N, Geusens P, Adachi JD, Messina OD, Morales-Torres J, Emkey R, Butler PW, Yin X, Lems WF. Denosumab Versus Risedronate in Glucocorticoid-Induced Osteoporosis: Final Results of a Twenty-Four-Month Randomized, Double-Blind, Double-Dummy Trial. Arthritis Rheumatol. 2019 Jul;71(7):1174-1184. doi: 10.1002/art.40874. Epub 2019 May 25.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2010-024393-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20101217
Identifier Type: -
Identifier Source: org_study_id
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