drugset / Trial / NCT03040531

Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

NCT03040531

RandomizedParallel-groupTriple-blindPrevention

Summary

Prolonged glucocorticoid therapy affects bone fragility, cardiovascular health, glucidic and lipidic metabolism, thyroid and brain function. Glucocorticoid-induced osteoporosis is characterized by low bone turnover and fractures, which occur in 30-50% of patients. Glucocorticoids affect predominantly cancellous or trabecular bone, increasing the risk of vertebral fractures, which may be asymptomatic and occur early during the first months of glucocorticoid treatment. Genistein exerts biological effects by several potential mechanisms. Besides protective effects on bone loss, genistein reduces cardiovascular risk markers, improves endothelial function and ameliorates glucose and lipid metabolism. This study is aimed at demonstrating genistein efficacy in glucocorticoid-induced osteoporosis in a cohort of caucasian post-menopausal women.

Timeline

Start
2017-01-19
Primary completion
2018-06-30
Completion
2018-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alendronic Acid Small molecule 70 mg Oral