Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
1380
Trial Sponsor
Trial Collaborator
Clinical Trial Start Date
2005
0Primary Completion Date
2006
0Study Completion Date
2006
0Clinical Trial Study Type
Observational0
Intervention Type
Dietary Supplement0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Official Name
Safety Profile and Bone Efficacy of the Phytoestrogen Genistein in a Cohort of Osteopenic, Postmenopausal Women After Three Years of Treatment: a Follow-up Study0
Last Updated
May 19, 2009
0Other attributes
Intervention Treatment
aglycone genistein0
placebo0
Study summary
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).
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