Clinical Data

Primary clinical data

To date, studies of one, two and three years have been completed on the efficacy and safety of genistein in Fosteum. Some of the associated publications are listed below.

  • Marini [file, 17.34KB] — The results of this two-year study were published in Annals of Internal Medicine, June 19, 2007. This study showed that the genistein in Fosteum, in combination with calcium and vitamin D, produced a gain in BMD of approximately 5% compared with baseline and approximately 8% compared with calcium and vitamin D alone. No markers of cancer were seen in breast or endometrium.
  • Morabito [file, 14.72KB] — The results of this one-year study of the genistein in Fosteum compared with HRT and placebo were published in Journal of Bone and Mineral Metabolism, October 2002. In the study all patients received calcium and vitamin D. This study showed that this genistein, in combination with calcium and vitamin D, produced a gain in BMD of approximately 3.3% compared with baseline. This was equal to HRT and 4.5% greater than calcium and vitamin D alone.
  • Burnett [file, 15.29KB] — The overall results of three years of administration of genistein with calcium and vitamin D compared with calcium and vitamin D alone were presented in a poster at the 7th International Symposium on Osteoporosis, April 2007, Washington, D.C.
  • D’Anna [file, 12.56KB] — This one-year study showed that the genistein in Fosteum is effective at reducing both hot flash number and severity. The effect was statistically significant at the first measurement (one month) and continued to be statistically significant at each time point through 12 months. At 12 months the average reduction in number and severity of hot flashes was 57% and 38%, respectively. No changes were observed in endometrial thickness or vaginal cytology. Of note is the lack of placebo effect shown in this study. The information on hot flashes was taken from journals kept by the study participants, but they were told only that they were being studied for bone, never for vasomotor symptoms.
  • Squadrito [file, 11.77KB] — This 12 month study reported that administration of the genistein in Fosteum improves flow-mediated, endothelium-dependent vasodilation to the same extent as HRT.

Supporting Data

  • Crisafulli, et al. 2005 Effects of the phytoestrogen genistein on cardiovascular risk factors in postmenopausal women. Menopause, 12(2), 186-192.
  • Altavilla, et al. 2004 Cardiovascular Effects of the Phytoestrogen Genistein Curr. Med. Chem. – Cardiovascular & Hematological Agents, 2, 179-186
  • Deodato, et al. 1999 Cardioprotection by the phytoestrogen genistein in experimental myocardial ischaemia-reperfusion injury British Journal of Pharmacology 128, 1683 – 1690
  • Squadrito, et al. 2002. The effect of the phytoestrogen genistein on plasma nitric oxide concentrations, endothelin-1 levels and endothelium dependent vasodilation in postmenopausal women. Atherosclerosis 163, 339-347.
  • D’Anna, et al. 2005 The effect of the phytoestrogen genistein and hormone replacement therapy on homocysteine and C-reactive protein level in postmenopausal women. Acta Obstet Gynecol Scand 84: 474—477
  • Uchiyama, S and Yamaguchi, M. 2007 Genistein and zinc synergistically stimulate apoptotic cell death and suppress RANKL signalin-related gene expression in osteoclastic cells. J Cell Biol. 101. 529-542.
  • Yamaguchi, et al., 2005. Prolonged intake of dietary fermented isoflavone-rich soybean reinforced with zinc affects circulating bone biochemical markers in aged individuals. Journal of Health Sciences. 51(2) 191-196.
  • Zhang, et al., 2005. Prospective cohort study of soy food consumption and risk of bone fracture among postmenopausal women. Arch Intern Med. Sep 12; 165(16) 1890-1895.

Last modified on 07-26-2007