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Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

Primary Purpose

Menopause, Osteopenia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Genistein
Sponsored by
University of Messina
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring Post-Menopausal Women, Osteoporosis, Phytoestrogen, Genistein

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: At least one year of menopause No use of hormone replacement therapy Bone mineral density T-score at the femoral neck minor than one S.D. Exclusion Criteria: Concomitant disease Smoke habit

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Efficacy:
    bone resorption/formation
    bone mineral density
    cardiovascular risk factors
    Safety:
    endometrial thickness

    Secondary Outcome Measures

    Efficacy:
    hot flushes reduction
    Safety:
    mammography
    vaginal cells maturation value

    Full Information

    First Posted
    July 24, 2006
    Last Updated
    April 18, 2008
    Sponsor
    University of Messina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00355953
    Brief Title
    Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Messina

    4. Oversight

    5. Study Description

    Brief Summary
    The present research program is proposed deepening some pharmacological effects of the genistein therapy in order to individualize alternative treatments to the conventional hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and the osteoporotic consequences in postmenopausal women.
    Detailed Description
    Genistein is a phytoestrogen of the isoflavone family which has been shown to have beneficial effects on endothelial function and bone metabolism. On the basis of the so far obtained results, aim of our research was to investigate for a two years period the effects of genistein on cardiovascular risk factors, endothelial function and oxidative stress markers, bone metabolism and finally clarify pathophysiology mechanisms (by dosage of cytokines and endothelial markers) by which this molecule could interfere on atherosclerosis and bone mass loss progression. Particularly, and in extreme synthesis the following parameters have been studied during the treatment: inflammation markers as fibrinogen lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, lipoprotein(a)- endothelial function markers as VCAM-1 and ICAM-1 oxidative stress by the evaluation of the F(2)-isoprostane cytokines as IL-6, OPG, RANK and RANKL bone mineral density, by DEXA, at lumbar spine and femoral neck Bone turnover markers as B-ALP, PYR, D-PYR PAP-test, transvaginal uterine ecography and mammography.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menopause, Osteopenia
    Keywords
    Post-Menopausal Women, Osteoporosis, Phytoestrogen, Genistein

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    400 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Genistein
    Primary Outcome Measure Information:
    Title
    Efficacy:
    Title
    bone resorption/formation
    Title
    bone mineral density
    Title
    cardiovascular risk factors
    Title
    Safety:
    Title
    endometrial thickness
    Secondary Outcome Measure Information:
    Title
    Efficacy:
    Title
    hot flushes reduction
    Title
    Safety:
    Title
    mammography
    Title
    vaginal cells maturation value

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least one year of menopause No use of hormone replacement therapy Bone mineral density T-score at the femoral neck minor than one S.D. Exclusion Criteria: Concomitant disease Smoke habit
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francesco Squadrito, MD
    Organizational Affiliation
    University of Messina
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17577003
    Citation
    Marini H, Minutoli L, Polito F, Bitto A, Altavilla D, Atteritano M, Gaudio A, Mazzaferro S, Frisina A, Frisina N, Lubrano C, Bonaiuto M, D'Anna R, Cannata ML, Corrado F, Adamo EB, Wilson S, Squadrito F. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):839-47. doi: 10.7326/0003-4819-146-12-200706190-00005.
    Results Reference
    derived

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    Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

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