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Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

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clinicaltrials.gov/study/NCT03040531
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT030405310
Trial Recruitment Size
2000
Trial Sponsor
University of Messina
University of Messina
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Clinical Trial Start Date
January 19, 2017
0
Primary Completion Date
June 30, 2018
0
Study Completion Date
December 30, 2018
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Drug0
Dietary Supplement0
Intervention Name
Genistein aglycone0
Alendronate Oral Tablet0
Calcium + vitamin D3 tablet0
Interventional Trial Phase
Phase 20
Phase 30
Participating Facility
‌
University Hospital
0
University of Messina
University of Messina
0
Official Name
Metabolic, Endocrine, and Central Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis0
Last Updated
March 3, 2017
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Triple0
Masked Party
Investigator0
Care Provider0
Participant0
Study 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.

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