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Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women

This study has been completed.
Sponsor:
Information provided by:
University of Messina
ClinicalTrials.gov Identifier:
NCT00355953
First received: July 24, 2006
Last updated: April 18, 2008
Last verified: April 2008
History of Changes

July 24, 2006
April 18, 2008
January 2003
Not Provided
  • Efficacy:
  • bone resorption/formation
  • bone mineral density
  • cardiovascular risk factors
  • Safety:
  • endometrial thickness
Same as current
Complete list of historical versions of study NCT00355953 on ClinicalTrials.gov Archive Site
  • Efficacy:
  • hot flushes reduction
  • Safety:
  • mammography
  • vaginal cells maturation value
Same as current
Not Provided
Not Provided
 
Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
Not Provided

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.

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:

  1. inflammation markers as fibrinogen
  2. lipid profile - total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, lipoprotein(a)-
  3. endothelial function markers as VCAM-1 and ICAM-1
  4. oxidative stress by the evaluation of the F(2)-isoprostane
  5. cytokines as IL-6, OPG, RANK and RANKL
  6. bone mineral density, by DEXA, at lumbar spine and femoral neck
  7. Bone turnover markers as B-ALP, PYR, D-PYR
  8. PAP-test, transvaginal uterine ecography and mammography.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Menopause
  • Osteopenia
Drug: Genistein
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
June 2005
Not Provided

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
Female
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00355953
2002067398
Not Provided
Not Provided
University of Messina
Not Provided
Study Director: Francesco Squadrito, MD University of Messina
University of Messina
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP