Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids

Completed · Phase 3 · Has a placebo group

Conditions studied: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

In brief

This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

Key facts

Study ID

NCT01575873

Run by

Amgen

People needed

795

Starts

2012-03-28

Expected to finish

2017-06-29

Last updated by the study team

2018-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Research Site — Sacramento, California, United States
• Research Site — Lakewood, Colorado, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Gainesville, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Cumberland, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Fargo, North Dakota, United States
• Research Site — Fargo, North Dakota, United States
• Research Site — Mayfield, Ohio, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Wyomissing, Pennsylvania, United States
• Research Site — Beckley, West Virginia, United States
• Research Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Research Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• Research Site — Buenos Aires, Argentina
• Research Site — Brussels, Belgium
• Research Site — Genk, Belgium
• Research Site — Ghent, Belgium
• Research Site — Liège, Belgium
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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