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Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040531
Recruitment Status : Unknown
Verified March 2017 by Francesco Squadrito, University of Messina.
Recruitment status was:  Recruiting
First Posted : February 2, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Ministry of Health, Italy
Information provided by (Responsible Party):
Francesco Squadrito, University of Messina

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis, Steroid Induced Dietary Supplement: Genistein aglycone Drug: Alendronate Oral Tablet Dietary Supplement: Calcium + vitamin D3 tablet Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Drugs will be labelled as "A" and "B" and so will be the groups. Patients and doctors involved will not be aware of the treatment.
Primary Purpose: Prevention
Official Title: Metabolic, Endocrine, and Central Effects of Genistein Aglycone in Glucocorticoid Induced Osteoporosis
Actual Study Start Date : January 19, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Genistein

Each tablet will contain 27 mg of 98% pure genistein + 500mg Calcium + 200 IU Vit. D3. Subjects will receive 2 tablets per day 6 days/week for all the duration of the study.

Once a week subjects will receive a tablet containing only 500mg Calcium + 200 IU Vit. D3.

Dietary Supplement: Genistein aglycone
27mg bid in tablets
Other Name: fosteum

Active Comparator: Alendronate

Each tablet will contain 500mg Calcium + 200 IU Vit. D3. Subjects will receive 2 tablets per day 6 days/week for all the duration of the study.

Once a week subjects will take one tablet containing 70mg alendronate.

Drug: Alendronate Oral Tablet
70 mg/week in tablets
Other Name: Fosamax

Dietary Supplement: Calcium + vitamin D3 tablet
500mg Calcium + 200 IU Vitamin D3 bid in tablets




Primary Outcome Measures :
  1. Change in Bone mineral density [ Time Frame: 24 months ]
    BMD of lumbar spine and femoral will be measured by DEXA (dual energy x-ray absorptiometry)

  2. Bone fracture [ Time Frame: 24 months ]
    Xrays of the lumbar spine (T4-L4) will be taken to evaluate the presence of fractures

  3. Change in Bone quality [ Time Frame: 24 months ]
    pQCT (peripheral quantitative computed tomography) will be used for bone quality evaluation


Secondary Outcome Measures :
  1. Change in Bone markers [ Time Frame: 24 months ]
    bone turnover markers will be evaluated on peripheral blood

  2. Change in Cardiovascular markers [ Time Frame: 24 months ]
    Markers of cardiovascular risk will be evaluated on peripheral blood

  3. Change in Glucose and lipid metabolism [ Time Frame: 24 months ]
    Glycaemia and blood lipids will be evaluated on peripheral blood

  4. Change in Quality of life [ Time Frame: 24 months ]
    European Quality of Life Questionnaire will be administered to subjects

  5. Chage in skin elasticity [ Time Frame: 24 months ]
    skin elasticity will be tested in subjects taking glucocorticoids

  6. Change in thyroid markers [ Time Frame: 24 months ]
    markers of thyroid function will be evaluated on peripheral blood

  7. Change in inflammatory markers [ Time Frame: 24 months ]
    markers of inflammation will be evaluated on peripheral blood

  8. Polymorphisms of estrogen receptor [ Time Frame: 24 months ]
    Estrogen receptor polymorphisms will be evaluated on white blood cells



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Ages Eligible for Study:   54 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female XX patients will be included, to avoid interactions with other steroid drugs.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • being treated with glucocorticoids (5 mg of prednisone equivalents) for the preceding 3 months or less, and expect to continue the therapy for at least 12 months;
  • being post-menopausal;

Exclusion Criteria:

  • use of other steroids or osteoporosis medications;
  • have been diagnosed with metabolic bone diseases (other than glucocorticoid osteoporosis)
  • previous (1 year) or current use of HRT (hormone replacement therapy)
  • other diseases that may affect participation (i.e. mental illness)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040531


Contacts
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Contact: Francesco Squadrito, MD +390902213648 fsquadrito@unime.it

Locations
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Italy
University of Messina Recruiting
Messina, Italy, 98123
Principal Investigator: Francesco Squadrito, MD         
University Hospital Recruiting
Messina, Italy, 98125
Contact: Francesco Squadrito, MD    +390902213648    fsquadrito@unime.it   
Principal Investigator: Marco Atteritano, MD         
Sub-Investigator: Alessandra Bitto, MD/PhD         
Sponsors and Collaborators
University of Messina
Ministry of Health, Italy
Investigators
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Study Director: Francesco Squadrito, MD University of Messina
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Responsible Party: Francesco Squadrito, Full Professor of Pharmacology, University of Messina
ClinicalTrials.gov Identifier: NCT03040531    
Other Study ID Numbers: 45/16
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Squadrito, University of Messina:
glucocorticoid
genistein
alendronate
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Cholecalciferol
Alendronate
Genistein
Calcium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists