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Acta Physiologica 2008; Volume 194, Supplement 665
The 59th National Congress of the Italian Physiological Society
9/17/2008-9/19/2008
Cagliari, Italy
SAFETY AND EFFICACY OF GENISTEIN IN OSTEOPENIC, POSTMENOPAUSAL WOMEN: A FOLLOW-UP STUDY
Abstract number: OC47
MARINI1 H, BITTO2 A, ALTAVILLA2 D, MINUTOLI2 L, POLITO2 F, ATTERITANO3 M, D'ANNA4 R, FRISINA3 N, CANCELLIERI4 F, ADAMO1 EB, SANSOTTA5 C, LUBRANO6 C, MARINI1 R, BURNETT7 B, LEVY7 R, SQUADRITO2 F
1Dept. of Biochemical, Physiological and Nutritional Sciences, Section of Physiology and Human Nutrition
2Dept. of Clin. and Exp. Medicine and Pharmacology, Section of Pharmacology
3Dept. of Internal Medicine
4Dept. of Obst. and Gynecol. Sciences
5Dept. of Env., San., Soc. and Ind. Protection, A.O.U. Policlinico G. Martino,University of Messina, Italy
6Dept. of Med. Physiop.,La Sapienza University, Rome, Italy
7Primus Pharmaceuticals, Inc. Scottsdale, Arizona, [email protected]
Aim:
We assessed the continued safety profile of genistein on breast and endometrium, and its effects on bone after 3 years of therapy. The parent study was a 2-year randomized, double-blind, placebo-controlled trial involving 389 osteopenic, postmenopausal women. Subsequently, a subcohort continued treatment for an additional year. Participants received genistein (54 mg/day) (n = 71) or placebo (n = 67). Both intervention and placebo contained calcium and vitamin D3.
Methods:
Mammographic breast density (MBD) was assessed at baseline, 24 and 36 months by visual classification scale and digitized quantification. BRCA1 and BRCA2, sister chromatid exchanges (SCE) and endometrial thickness (ET) were evaluated at the same time points. Lumbar spine and femoral neck bone mineral density (BMD) were also estimated. Secondary outcomes were biochemical bone markers.
Results:
After 36 months, genistein did not significantly change MBD or ET, BRCA1 and BRCA2 expression was preserved while SCE were reduced compared with placebo. BMD increases were greater with genistein for both femoral neck and lumbar spine compared to placebo. Genistein significantly reduced PYR as well as CTX and sRANKL while increasing B-ALP, IGF-I and OPG levels. There were no differences in adverse events between groups.
Conclusions:
After 3-years of treatment, genistein exhibited a promising safety profile with positive effects on bone in a cohort of osteopenic, postmenopausal women.
To cite this abstract, please use the following information:
Acta Physiologica 2008; Volume 194, Supplement 665 :OC47