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Soy isoflavone supplementation and bone mineral density in menopausal women: a 2-y multicenter clinical trial^1,2,3,4

¹ From the US Department of Agriculture/Agricultural Research Service, Children’s Nutrition Research Center, Baylor College of Medicine, Houston, TX (WWW, PA, RLY, KJE, RJS, JKF, KLK, and EOS); the University of Georgia, Athens, GA (RDL, MAC, and JGF); the University of California, Davis, CA (FMS); the Kaiser Foundation Research Institute, Sacramento, CA (MJM); and the University of Alabama, Birmingham, AL (SB).

² The contents of this publication do not necessarily reflect the views or policies of the US Department of Agriculture or the NIH, nor does the mention of trade names, commercial products, or organizations imply endorsement.

³ Supported by the US Department of Agriculture/Cooperative State Research, Education, and the Extension Service/Initiatives for Future Agriculture and Food Systems (grant no. 2001-52102-11255) and by the NIH General Clinical Research Center (grant no. M01-RR00188). The soy isoflavone material was provided by Frutarum Netherlands BV (Veenendaal, Netherlands). The placebo and isoflavone tablets were manufactured and packaged by Pharma Consulting & Industries BV (Eede, Netherlands). The one-a-day multivitamin supplement was provided by Swanson Health Products, Fargo, ND. The calcium carbonate supplement was provided by Source Naturals, Scotts Valley, CA.

⁴ Address correspondence to WW Wong, USDA/ARS Children’s Nutrition Research Center, 1100 Bates Street, Houston, TX 77030. E-mail: wwong{at}bcm.edu.

Background: Isoflavones are naturally occurring plant estrogens that are abundant in soy. Although purported to protect against bone loss, the efficacy of soy isoflavone supplementation in the prevention of osteoporosis in postmenopausal women remains controversial.

Objective: Our aim was to test the effect of soy isoflavone supplementation on bone health.

Design: A multicenter, randomized, double-blind, placebo-controlled 24-mo trial was conducted to assess the effects of daily supplementation with 80 or 120 mg of soy hypocotyl aglycone isoflavones plus calcium and vitamin D on bone changes in 403 postmenopausal women. Study subjects were tested annually and changes in whole-body and regional bone mineral density (BMD), bone mineral content (BMC), and T scores were assessed. Changes in serum biochemical markers of bone metabolism were also assessed.

Results: After study site, soy intake, and pretreatment values were controlled for, subjects receiving a daily supplement with 120 mg soy isoflavones had a statistically significant smaller reduction in whole-body BMD than did the placebo group both at 1 y (P < 0.03) and at 2 y (P < 0.05) of treatment. Smaller decreases in whole-body BMD T score were observed among this group of women at 1 y (P < 0.03) but not at 2 y of treatment. When compared with the placebo, soy isoflavone supplementation had no effect on changes in regional BMD, BMC, T scores, or biochemical markers of bone metabolism.

Conclusion: Daily supplementation with 120 mg soy hypocotyl isoflavones reduces whole-body bone loss but does not slow bone loss at common fracture sites in healthy postmenopausal women. This trial was registered at clinicaltrials.gov as NCT00665860.