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.
A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
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).
Steroid-induced Osteopor Glucocorticoid-induced Ostepor GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density Denosumab Risedronate Sodium Etidronic Acid Glucocorticoids
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.
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.
© 2017 The Regents of the University of California