Third Year Evaluation on Genistein Efficacy and Safety
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|ClinicalTrials.gov Identifier: NCT00626769|
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : May 19, 2009
BACKGROUND: Recent evidences showed that the phytoestrogen genistein positively affects bone metabolism with no clinically significant adverse effects in a cohort of osteopenic, postmenopausal women. However, there is still a knowledge gap regarding the long-term safety of genistein on the breast, the uterus, the thyroid gland and its efficacy in postmenopausal women.
OBJECTIVE: To assess the safety profile of genistein on mammary and thyroid glands and endometrium and cardiovascular apparatus and its effects on bone metabolism after a 3-year therapy with pure, standardized genistein (54 mg/day).
|Condition or disease||Intervention/treatment||Phase|
|Menopause Osteopenia||Dietary Supplement: aglycone genistein Dietary Supplement: placebo||Phase 2 Phase 3|
DESIGN: The parent study was a randomized, double-blind, placebo-controlled trial involving 389 osteopenic, postmenopausal women for 24 months. After the 24-month visit, a sub-population (138 patients) accepted to continue the intervention until 36 months, thus generating a follow-up study.
SETTING: 3 Italian university medical centers. INTERVENTIONS: Participants received 54 mg of genistein, daily, (n=71) or placebo (n=67). Both intervention and placebo contained calcium and vitamin D3. All patients also received dietary instruction in an isocaloric fat-reduced diet.
MEASUREMENTS: Mammographic breast density at baseline and after 24 and 36 months was assessed by visual classification scale and by digitized quantification. BRCA1 and BRCA2 molecular message, sister chromatid exchanges and endometrial thickness were also evaluated at the same time points. Measurements of lumbar spine and femoral neck BMD and QUS t-score were assayed in our patients. Secondary outcomes were serum levels of B-ALP, IGF-I, sRANKL, osteoprotegerin and urinary excretion of CTX, pyridinoline and deoxypyridinoline. Furthermore insulin resistance (HOMA-IR), glucose levels, homocysteine and hot flushes were also evaluated. In addition for thyroid safety TSH, fT3, fT4, thyroid autoantibodies, and mRNA for thyroid and retinoid receptors were evaluated.
|Study Type :||Observational|
|Actual Enrollment :||138 participants|
|Official Title:||Safety Profile and Bone Efficacy of the Phytoestrogen Genistein in a Cohort of Osteopenic, Postmenopausal Women After Three Years of Treatment: a Follow-up Study|
|Study Start Date :||July 2005|
|Primary Completion Date :||July 2006|
|Study Completion Date :||September 2006|
Postmenopausal women with established osteopenia receiving aglycone genistein 54 mg/day for 3 years
Dietary Supplement: aglycone genistein
2 capsules per day containing 27 mg of aglycone genistein, calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
Postmenopausal women with established osteopenia receiving placebo (Calcium and vitD) for 3 years
Dietary Supplement: placebo
2 capsules per day containing calcium carbonate (500 mg) and vitamin D (400 IU), for a 3-year period.
- Bone Mineral Density [ Time Frame: basal and after 1 year ]
- Mammographic breast density [ Time Frame: basal and after 3 years ]
- Bone-specific alkaline phosphatase (B-ALP) [ Time Frame: basal and after 1 year ]
- Insulin-like growth factor 1 (IGF-1) [ Time Frame: basal and after 1 year ]
- Pyridinium cross-links (pyridinoline and deoxypyridinoline) [ Time Frame: basal and after 1 year ]
- carboxy-terminal cross-linking telopeptide (CTX) [ Time Frame: basal and after 1 year ]
- Osteoprotegerin and soluble receptor activator of NF-kB ligand (s-RANKL) [ Time Frame: basal and after 1 year ]
- BRCA1 and BRCA2 mRNA levels [ Time Frame: basal and after 3 years ]
- Sister Chromatid exchanges [ Time Frame: basal and after 3 years ]
- Endometrial thickness [ Time Frame: basal and after 3 years ]
- Insulin resistance [ Time Frame: basal and after 3 years ]
- hot flushes [ Time Frame: basal and after 3 years ]
- Thyroid status [ Time Frame: basal and after 3 years ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626769
|Principal Investigator:||Francesco Squadrito, MD||University of Messina|
|Study Director:||Rosario D'Anna, MD||University of Messina|