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