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Effects of the Phytoestrogen Genistein on Bone Metabolism in Osteopenic Postmenopausal Women: A Randomized Trial

Herbert Marini, MD; Letteria Minutoli, MD; Francesca Polito, PhD; Alessandra Bitto, MD; Domenica Altavilla, PhD; Marco Atteritano, MD; Agostino Gaudio, MD; Susanna Mazzaferro, MD; Alessia Frisina, MD; Nicola Frisina, MD; Carla Lubrano, MD; Michele Bonaiuto, MD; Rosario D'Anna, MD; Maria Letizia Cannata, MD; Francesco Corrado, MD; Elena Bianca Adamo, MD; Steven Wilson, PhD; and Francesco Squadrito, MD
[+] Article and Author Information

From Azienda Ospedaliera Universitaria Policlinico “G. Martino,” University of Messina, Messina, Italy.


Grant Support: By the Italian Ministry of Education, University, and Research and the University of Messina.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Francesco Squadrito, MD, Department of Experimental and Clinical Medicine and Pharmacology, Section of Pharmacology, Torre Biologica, 5th Floor, Azienda Ospedaliera Universitaria Policlinico “G. Martino,” Via C. Valeria, 98125 Messina, Italy; e-mail, Francesco.Squadrito@unime.it.

Current Author Addresses: Drs. Marini and Adamo: Department of Biochemical, Physiological and Nutritional Sciences, Section of Physiology and Human Nutrition, Azienda Ospedaliera Universitaria Policlinico “G. Martino,” Via C. Valeria, 98125 Messina, Italy.

Drs. Minutoli, Polito, Bitto, Altavilla, and Squadrito: Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, Azienda Ospedaliera Universitaria Policlinico “G. Martino,” Via C. Valeria, 98125 Messina, Italy.

Drs. Atteritano, Gaudio, Mazzaferro, A. Frisina, N. Frisina, and Bonaiuto: Department of Internal Medicine, Azienda Ospedaliera Universitaria Policlinico “G. Martino,” Via C. Valeria, 98125 Messina, Italy.

Dr. Lubrano: Department of Medical Physiopathology, “La Sapienza” University, Rome, Italy.

Drs. D'Anna, Cannata, and Corrado: Department of Obstetrical and Gynecological Sciences, Azienda Ospedaliera Universitaria Policlinico “G. Martino,” Via C. Valeria, 98125 Messina, Italy.

Dr. Wilson: Department of Health Initiatives, National Jewish Medical and Research Center, Denver, CO 80206.

Author Contributions: Conception and design: H. Marini, R. D'Anna, F. Squadrito.

Analysis and interpretation of the data: H. Marini, L. Minutoli, F. Polito, R. D'Anna, S. Wilson, F. Squadrito.

Drafting of the article: H. Marini, A. Bitto, D. Altavilla, R. D'Anna, F. Squadrito.

Critical revision of the article for important intellectual content: H. Marini, R. D'Anna, F. Squadrito.

Provision of study materials or patients: M. Atteritano, A. Gaudio, S. Mazzaferro, A. Frisina, N. Frisina, C. Lubrano, M. Bonaiuto, R. D'Anna, M.L. Cannata, F. Corrado, E.B. Adamo.

Obtaining of funding: N. Frisina, C. Lubrano, R. D'Anna.

Administrative, technical or logistic support: N. Frisina, R. D'Anna, F. Squadrito.

Collection and assembly of data: H. Marini, L. Minutoli, F. Polito.


Ann Intern Med. 2007;146(12):839-847. doi:10.7326/0003-4819-146-12-200706190-00005
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We found that treatment with genistein, an abundant soy isoflavone, prevents bone loss caused by estrogen deficiency without affecting the uterus in osteopenic postmenopausal women. Genistein decreased levels of bone resorption markers and increased levels of markers of new bone formation, producing a net gain in bone mass after 1 year and 2 years of therapy. Nevertheless, although BMD and bone markers are considered good surrogates of bone strength and bone quality, they may not correlate perfectly with reduction in fracture risk.

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Grahic Jump Location
Figure 2.
Change in bone mineral density (BMD) over time.

Estimates are expected means from mixed-effects models. *P < 0.001 vs. placebo.

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Grahic Jump Location
Figure 3.
Changes in biochemical variables over time.

Estimates are expected means from mixed-effects models. ALP = alkaline phosphatase. *P = 0.001 vs. placebo. †P < 0.001 vs. placebo. ‡P = 0.002 vs. placebo.

Grahic Jump Location

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Geographic Differences in Dietary Influences May Play a Bigger Issue in Postmenopausal Women
Posted on July 19, 2007
An T. Tran
Howard University College of Medicine
Conflict of Interest: None Declared

It is with great interest that we reviewed the article "Effects of the Phytoestrogen Genistein on Bone Metabolism in Osteopenic Postmenopausal Women " by Marini et al. The result on Genistein is very promising, however, there are several concerns we would like to address. Firstly, it would be of great benefit if this study is done in a more diverse setting not just limited to 3 university medical centers in Italy. A confounding variable is if the Mediterranean diet, which is high in green vegetables and goat cheese (a good source of calcium and iron) contributes to the result. One would wonder if the result is the same if the study is done in the United States where the diet composition is different and the population more diverse.

Secondly, the patient sample chosen is by the study did not mention the activity levels of the participants. One would expect that the more active and fit the patient, the healthier the bone and therefore it would be vital to control for activity levels.

Thirdly, further studies on the long term effect of Genistein would be important to examine the safety of this medicine beyond 2 years. Previous studies have shown that high estrogen post an increase risk in breast/ovarian/endometrial cancer, blood clots, cardiovascular and other complications. Therefore, these side effects must be address future studies. Also, the incident of bone fractures are most critical in the evaluation of the utility of Genistein as mentioned in the article.

Despite these issues, the risk/benefit ratio of Genistein may warrant further studies and use in the postmenopausal population.

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Summary for Patients

Effects of the Phytoestrogen Genistein on Bone Health in Postmenopausal Women

The summary below is from the full report titled “Effects of the Phytoestrogen Genistein on Bone Metabolism in Osteopenic Postmenopausal Women. A Randomized Trial.” It is in the 19 June 2007 issue of Annals of Internal Medicine (volume 146, pages 839-847). The authors are H. Marini, L. Minutoli, F. Polito, A. Bitto, D. Altavilla, M. Atteritano, A. Gaudio, S. Mazzaferro, A. Frisina, N. Frisina, C. Lubrano, M. Bonaiuto, R. D'Anna, M.L. Cannata, F. Corrado, E.B. Adamo, S. Wilson, and F. Squadrito.

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