Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women - Full Text View

Sponsored by:	University of Messina
Information provided by:	University of Messina
ClinicalTrials.gov Identifier:	NCT00355953

Purpose

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.

Condition	Intervention	Phase
Menopause Osteopenia	Drug: Genistein	Phase II Phase III

MedlinePlus related topics: Menopause

Drug Information available for: Genistein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by University of Messina:

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

Estimated Enrollment:	400
Study Start Date:	January 2003
Estimated Study Completion Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355953

Sponsors and Collaborators

University of Messina

Investigators

Study Director:

Francesco Squadrito, MD

University of Messina

More Information

Publications indexed to this study:

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.

Study ID Numbers:	2002067398
Study First Received:	July 24, 2006
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00355953
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Messina:

Post-Menopausal Women
Osteoporosis
Phytoestrogen
Genistein

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic

Bone Diseases
Genistein
Menopause

Additional relevant MeSH terms:

Anticarcinogenic Agents
Estrogens
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors

Hormones
Protective Agents
Protein Kinase Inhibitors
Pharmacologic Actions
Estrogens, Non-Steroidal
Therapeutic Uses
Phytoestrogens

ClinicalTrials.gov processed this record on January 14, 2009