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Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

NCT03040531 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-03-03

No results posted yet for this 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.

Conditions

  • Osteoporosis, Steroid Induced

Interventions

DIETARY_SUPPLEMENT

Genistein aglycone

27mg bid in tablets

DRUG

Alendronate Oral Tablet

70 mg/week in tablets

DIETARY_SUPPLEMENT

Calcium + vitamin D3 tablet

500mg Calcium + 200 IU Vitamin D3 bid in tablets

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • University of Messina

    lead OTHER

Principal Investigators

  • Francesco Squadrito, MD · University of Messina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
54 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040531 on ClinicalTrials.gov