Menopause Clinical Trial
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
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).
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.
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Observational Model: Cohort, Time Perspective: Prospective
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