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

Update Il y a 5 ans
Reference: EUCTR2010-024393-19

Woman and Man

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Extract

The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg subcutaneously (SC) every 6 months (Q6M) is not inferior to treatment with oral risedronate 5 mg every day (QD) with respect to the percent change from baseline in lumbar spine bone mineral density (BMD) by dual X-ray absorptiometry (DXA) at 12 months. The primary objective in the glucocorticoid-initiating subpopulation of men and women treated with glucocorticoid therapy is to demonstrate that treatment with denosumab 60 mg SC Q6M is not inferior to treatment with oral risedronate 5 mg QD with respect to the percent change from baseline in lumbar spine BMD by DXA at 12 months.


Inclusion criteria

  • Glucocorticoid-induced osteoporosis