Clinical trial NCT00355953: Vascular and Skeletal Protective Effects of Genistein in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Menopause
Osteopenia
Keywords: Post-Menopausal Women
Osteoporosis
Phytoestrogen
Genistein
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2006-07-25
Enrollment: 400
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Efficacy:
measure: bone resorption/formation
measure: bone mineral density
measure: cardiovascular risk factors
measure: Safety:
measure: endometrial thickness
Secondary outcomes:
measure: Efficacy:
measure: hot flushes reduction
measure: Safety:
measure: mammography
measure: vaginal cells maturation value
Other outcomes:
Locations:
Study officials:
affiliation: University of Messina
name: Francesco Squadrito, MD
role: STUDY_DIRECTOR
References:
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.