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Eligibility
for people ages 18 years and up
Location
at Sacramento, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This study is being conducted in patients taking glucocorticoids for treatment of various diseases. It is a 2-year study that will compare the effects of denosumab and risedronate.

Official Title

A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

Details

This is a 2-year study that will compare the effects of denosumab and risedronate in people who are taking glucocorticoid therapy. The study will look at bone mineral density (BMD) at the spine and hip during two years of treatment. Other endpoints will include changes in wrist characteristics measured by QCT, satisfaction with treatment, effects on biochemical markers of bone turnover (blood tests that can measure bone health), fracture rates, and effects on bone histology (characteristics of bone that can be studied under a microscope).

Keywords

Steroid-induced Osteopor Glucocorticoid-induced Ostepor GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density Denosumab Risedronate Sodium Etidronic Acid Glucocorticoids

Eligibility

You can join if…

Open to people ages 18 years and up

Men and women 18 years of age or older who have been taking glucocorticoid treatment. Men and women who are less than 50 years of age must have had a fracture as an adult to be eligible. Men and women who are 50 years of age or older who have been taking glucocorticoids must meet protocol-specific BMD criteria.

You CAN'T join if...

Use of agents affecting bone metabolism, use of more than one biologic agent for inflammatory disease, history of bone disease (except osteoporosis), low vitamin D level (one can enter the trial after vitamin D levels are corrected), abnormalities of blood calcium, an underactive or overactive thyroid condition that is not treated and stable, Addison's disease, any abnormality of the parathyroid glands (the glands that control blood calcium), currently pregnant or planning a pregnancy, currently breast feeding, and other criteria may apply.

Locations

  • Research Site
    Sacramento, California, 95817, USA
  • Research Site
    Birmingham, Alabama, 35294, USA
  • Research Site
    Lakewood, Colorado, 80227, USA
  • Research Site
    Pembroke Pines, Florida, 33029, USA
  • Research Site
    Gainesville, Georgia, 30501, USA
  • Research Site
    Chicago, Illinois, 60611, USA
  • Research Site
    Evanston, Illinois, 60201, USA
  • Research Site
    Indianapolis, Indiana, 46202, USA
  • Research Site
    Bethesda, Maryland, 20817, USA
  • Research Site
    Cumberland, Maryland, 21502, USA
  • Research Site
    Boston, Massachusetts, 02118, USA
  • Research Site
    Detroit, Michigan, 48236, USA
  • Research Site
    Fargo, North Dakota, 58103, USA
  • Research Site
    Fargo, North Dakota, 58104, USA
  • Research Site
    Mayfield Village, Ohio, 44143, USA
  • Research Site
    Duncansville, Pennsylvania, 16635, USA
  • Research Site
    Wyomissing, Pennsylvania, 19610, USA
  • Research Site
    Beckley, West Virginia, 25801, USA
  • Research Site
    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1114, Argentina
  • Research Site
    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF, Argentina
  • Research Site
    Buenos Aires, C1431FBO, Argentina
  • Research Site
    Bruxelles, 1200, Belgium
  • Research Site
    Genk, 3600, Belgium
  • Research Site
    Gent, 9000, Belgium
  • Research Site
    Liege, 4000, Belgium
  • Research Site
    Wilrijk, 2610, Belgium
  • Research Site
    Vancouver, British Columbia, V5Z 4E1, Canada
  • Research Site
    Barrie, Ontario, L4M 6L2, Canada
  • Research Site
    Hamilton, Ontario, L8N 1Y2, Canada
  • Research Site
    Waterloo, Ontario, N2J 1C4, Canada
  • Research Site
    Montreal, Quebec, H2L 1S6, Canada
  • Research Site
    Montreal, Quebec, H3Z 2Z3, Canada
  • Research Site
    Trois-Rivieres, Quebec, G8Z 1Y2, Canada
  • Research Site
    Westmout, Quebec, H3Z 1E5, Canada
  • Research Site
    Saskatoon, Saskatchewan, S7K 0H6, Canada
  • Research Site
    Quebec, G1V 3M7, Canada
  • Research Site
    Barranquilla, Atlántico, 08001000, Colombia
  • Research Site
    Brno, 602 00, Czech Republic
  • Research Site
    Pardubice, 530 02, Czech Republic
  • Research Site
    Plzen, 305 99, Czech Republic
  • Research Site
    Praha 11 - Chodov, 148 00, Czech Republic
  • Research Site
    Praha 2, 128 50, Czech Republic
  • Research Site
    Praha 3, 130 00, Czech Republic
  • Research Site
    Uherske Hradiste, 686 01, Czech Republic
  • Research Site
    Aalborg, 9000, Denmark
  • Research Site
    Ballerup, 2750, Denmark
  • Research Site
    Vejle, 7100, Denmark
  • Research Site
    Århus C, 8000, Denmark
  • Research Site
    Lyon Cédex 3, 69437, France
  • Research Site
    Orleans Cedex, 45067, France
  • Research Site
    Vandoeuvre les Nancy, 54511, France
  • Research Site
    Bad Nauheim, 61231, Germany
  • Research Site
    Bad Reichenhall, 83435, Germany
  • Research Site
    Berlin, 10117, Germany
  • Research Site
    Hildesheim, 31134, Germany
  • Research Site
    Köln, 50937, Germany
  • Research Site
    Vogelsang-Gommern, 39245, Germany
  • Research Site
    Budapest, 1023, Hungary
  • Research Site
    Budapest, 1036, Hungary
  • Research Site
    Debrecen, 4032, Hungary
  • Research Site
    Gyula, 5700, Hungary
  • Research Site
    Szeged, 6720, Hungary
  • Research Site
    Szikszo, 3800, Hungary
  • Research Site
    Daegu, 700-712, Korea, Republic of
  • Research Site
    Daejeon, 301-721, Korea, Republic of
  • Research Site
    Gwangju, 501-757, Korea, Republic of
  • Research Site
    Jinju-si, 660-702, Korea, Republic of
  • Research Site
    Seoul, 120-752, Korea, Republic of
  • Research Site
    Seoul, 137-701, Korea, Republic of
  • Research Site
    Seoul, 150-713, Korea, Republic of
  • Research Site
    Mexico, Distrito Federal, 06100, Mexico
  • Research Site
    Leon, Guanajuato, 37000, Mexico
  • Research Site
    Morelia, Michoacán, 58070, Mexico
  • Research Site
    San Luis Potosi, San Luis Potosí, 78200, Mexico
  • Research Site
    Amsterdam, 1081 HV, Netherlands
  • Research Site
    Helmond, 5707 HA, Netherlands
  • Research Site
    Utrecht, 3584 XC, Netherlands
  • Research Site
    Bialystok, 15-879, Poland
  • Research Site
    Kraków, 31-501, Poland
  • Research Site
    Lodz, 90-368, Poland
  • Research Site
    Poznan, 60-218, Poland
  • Research Site
    Poznan, 60-356, Poland
  • Research Site
    Stalowa Wola, 37-450, Poland
  • Research Site
    Torun, 87-100, Poland
  • Research Site
    Warszawa, 01-192, Poland
  • Research Site
    Warszawa, 04-730, Poland
  • Research Site
    Wroclaw, 51-124, Poland
  • Research Site
    Ekaterinburg, 620102, Russian Federation
  • Research Site
    Moscow, 105077, Russian Federation
  • Research Site
    Moscow, 115522, Russian Federation
  • Research Site
    Nizhniy Novgorod, 603155, Russian Federation
  • Research Site
    Saint Petersburg, 190103, Russian Federation
  • Research Site
    Saint Petersburg, 194291, Russian Federation
  • Research Site
    Saint-Petersburg, 190068, Russian Federation
  • Research Site
    Yaroslavl, 150003, Russian Federation
  • Research Site
    Barcelona, Cataluña, 08041, Spain
  • Research Site
    Valencia, Comunidad Valenciana, 46026, Spain
  • Research Site
    Madrid, 28006, Spain
  • Research Site
    Madrid, 28046, Spain

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT01575873
Phase
Phase 3
Lead Scientist
Sharmila Majumdar
Study Type
Interventional
Last Updated
January 2017