Soy Isoflavones for Reducing Bone Loss Study: Effects of a 3-year trial on hormones, adverse events, and endometrial thickness in postmenopausal women

Menopause

Volumn 22, Issue 2, 2015, Pages 185-197

  Alekel, D Lee ^a   Genschel, Ulrike ^b   Koehler, Kenneth J ^b   Hofmann, Heike ^b   Van Loan, Marta D ^c   Beer, Bonnie S ^d   Hanson, Laura N ^e   Peterson, Charles T ^f   Kurzer, Mindy S ^g  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b Department of Statistics Center for Statistics and Applications in Forensic Evidence Iowa State University 2438 Osborn Dr Ames   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d McFarland Clinic   (United States)

^e MAYO CLINIC   (United States)

^f CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^g UNIVERSITY OF MINNESOTA   (United States)

Author keywords

17A Estradiol; Estrone sulfate; Safety; Soy isoflavone supplements; Thyroid stimulating hormone; Transvaginal ultrasound

Indexed keywords

DAIDZEIN; ESTRADIOL; ESTROGEN; ESTRONE SULFATE; GENISTEIN; GLYCITEIN; HORMONE; IRON; ISOFLAVONE DERIVATIVE; LOW DENSITY LIPOPROTEIN; PLACEBO; SEX HORMONE BINDING GLOBULIN; SOY ISOFLAVONE; THYROTROPIN; UNCLASSIFIED DRUG; ESTRONE; SOYBEAN PROTEIN;

ADULT; ADVERSE DRUG REACTION; AGED; ALCOHOL CONSUMPTION; ARTICLE; BACTERIAL INFECTION; BONE DENSITOMETRY; BONE DENSITY; CONTROLLED STUDY; CYST; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFECT; DRUG EXCRETION; DRUG INDUCED HEADACHE; DRUG MONITORING; DRUG SAFETY; DRUG URINE LEVEL; DUAL ENERGY X RAY ABSORPTIOMETRY; ENDOMETRIAL THICKNESS; ENDOMETRIUM BIOPSY; ESTRADIOL BLOOD LEVEL; ESTROGEN BLOOD LEVEL; FEMALE; FOLLOW UP; FREE THYROXINE INDEX; GASTROENTERITIS; GYNECOLOGICAL EXAMINATION; HORMONE BLOOD LEVEL; HUMAN; HUMAN TISSUE; HYSTEROSCOPY; INFLUENZA; INSOMNIA; IRON BLOOD LEVEL; JOINT INJURY; LIPOPROTEIN BLOOD LEVEL; MAJOR CLINICAL STUDY; MEDICATION COMPLIANCE; MULTICENTER STUDY; NORMAL HUMAN; OSTEOLYSIS; OTITIS MEDIA; OUTCOME ASSESSMENT; PAIN; PATIENT COMPLIANCE; POSTMENOPAUSE; PROSPECTIVE STUDY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINUSITIS; SOYBEAN; SPOTTING; THYROID FUNCTION; THYROTROPIN BLOOD LEVEL; TOOTH DISEASE; TRANSVAGINAL ECHOGRAPHY; TREATMENT DURATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; URINE LEVEL; UROGENITAL SYSTEM; ANALOGS AND DERIVATIVES; ANATOMY AND HISTOLOGY; BLOOD; DIAGNOSTIC IMAGING; DRUG EFFECTS; ECHOGRAPHY; ENDOMETRIUM; INTENTION TO TREAT ANALYSIS; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL;

AGED; DOUBLE-BLIND METHOD; ENDOMETRIUM; ESTRADIOL; ESTROGENS; ESTRONE; FEMALE; HUMANS; INTENTION TO TREAT ANALYSIS; ISOFLAVONES; MIDDLE AGED; OSTEOPOROSIS, POSTMENOPAUSAL; SEX HORMONE-BINDING GLOBULIN; SOYBEAN PROTEINS; THYROTROPIN; ULTRASONOGRAPHY;

EID: 84922406269     PISSN: 10723714     EISSN: 15300374     Source Type: Journal    
DOI: 10.1097/GME.0000000000000280     Document Type: Article

References (31)

1. Ursin G, Sun C-L, Koh W-P, et al. Associations between soy, diet, reproductive factors, and mammographic density in Singapore Chinese women. Nutr Cancer 2006;56:128-135
2. Palacios S, Pornel B, Vázquez F, Aubert L, Chantre P, Marès P. Longterm endometrial and breast safety of a specific, standardized soy extract. Climacteric 2010;13:368-375
3. Steinberg FM, Murray MJ, Lewis RD, et al. Clinical outcomes of a 2-y soy isoflavone supplementation in menopausal women. Am J Clin Nutr 2011;93:356-367
4. Colacurci N, De Franciscis P, Atlante M, et al. Endometrial, breast and liver safety of soy isoflavones plus Lactobacillus sporogenes in postmenopausal women. Gynecol Endocrinol 2013;29:209-212
5. D'Anna R, Cannata ML, Marini H, et al. Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 2-year randomized, double-blind, placebocontrolled study. Menopause 2009;16:301-306
6. Duncan AM, Underhill KE, Xu X, Lavalleur J, Phipps WR, Kurzer MS. Modest hormonal effects of soy isoflavones in postmenopausal women. J Clin Endocrinol Metab 1999;84:3479-3484
7. Unfer V, Casini ML, Castabile L, Mignosa M, Gerli S, Di Renzo GC. Endometrial effects of long-term treatment with phytoestrogens: a randomized, double-blind, placebo-controlled study. Fertil Steril 2004;82: 145-148
8. Alekel DL, Van Loan MD, Koehler KJ, et al. The Soy Isoflavones for Reducing Bone Loss (SIRBL) Study: a 3-y randomized controlled trial in postmenopausal women. Am J Clin Nutr 2010;91:218-230
9. Nielsen NR, GrLnbaek M. Interactions between intakes of alcohol and postmenopausal hormones on risk of breast cancer. Int J Cancer 2008; 122:1109-1113
10. Looker AC, Wahner HW, Dunn WL, et al. Updated data on proximal femur bone mineral levels of US adults. Osteoporos Int 1998;8:468-489
11. Alekel DL, St Germain A, Peterson CT, Hanson KB, Stewart JW, Toda T. Isoflavone-rich soy protein isolate attenuates bone loss in the lumbar spine of perimenopausal women. Am J Clin Nutr 2000;72:844-852
12. Alekel DL. Contributions of Physical Activity, Body Composition, Age, and Nutritional Factors to Total and Regional Bone Mass in Premenopausal Aerobic Dancers and Exercisers [PhD dissertation]. Urbana, IL: University of Illinois-Urbana; 1993
13. Morabia A, Costanza MC. International variability in ages at menarche, first live birth, and menopause: World Health Organization collaborative study of neoplasia and steroid contraceptives. Am J Epidemiol 1998;148:1195-1205
14. St Germain A, Peterson CT, Robinson J, Alekel DL. Isoflavone-rich or isoflavone-poor soy protein does not reduce menopausal symptoms during 24 weeks of treatment. Menopause 2001;8:17-26
15. Kirk P, Patterson RE, Lampe J. Development of a soy food frequency questionnaire to estimate isoflavone consumption in U.S. adults. J Am Diet Assoc 1999;99:558-563
16. Vermeulen A, Verdonck L, Kaufman JM. A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab 1999;84:3666-3672
17. Mazer NA. A novel spreadsheet method for calculating the free serum concentrations of testosterone, dihydrotestosterone, estradiol, estrone and cortisol: with illustrative examples from male and female populations. Steroids 2009;74:512-519
18. Hollis S, Campbell F. What is meant by intention to treat analysis?. Survey of published randomised controlled trials. Br Med J 1999;319:670-674
19. Allison PD. Multicollinearity. In: Logistic Regression Using the SAS SystemVTheory and Application. Cary, NC: SAS Institute Inc; 1999
20. Hooper L, Ryder JJ, Kurzer MS, et al. Effects of soy protein and isoflavones on circulating hormone concentrations in pre- and postmenopausal women: a systematic review and meta-analysis. Hum Reprod Update 2009;15:423-440
21. Atkinson C, Warren RM, Sala E, et al. Red cloverYderived isoflavones and mammographic breast density: a double-blind, randomized, placebocontrolled trial. Breast Cancer Res 2004;6:R170-R179
22. Levis S, Strickman-Stein N, Ganjei-Azar P, Xu P, Doerge DR, Krischer J. Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. Arch Intern Med 2011;171: 1363-1369
23. Bitto A, Polito F, Atteritano M, et al. Genistein aglycone does not affect thyroid function: results from a three-year, randomized, double-blind, placebo-controlled trial. J Clin Endocrinol Metab 2010;95:3067-3072
24. Upmalis DH, Lobo R, Bradley L, Warren M, Cone FL, Lamia CA. Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: a multicenter, double-blind, randomized, placebo-controlled study. Menopause 2000;7:236-242
25. Han KK, Soares JM Jr, Haidar MA, de Lima GR, Baracat EC. Benefits of soy isoflavone therapeutic regimen on menopausal symptoms. Obstet Gynecol 2002;99:389-394
26. Penotti M, Fabio E, Modena AB, Rinaldi M, Omodei U, Viganó P. Effect of soy-derived isoflavones on hot flushes, endometrial thickness, and the pulsatility index of the uterine and cerebral arteries. Fertil Steril 2003; 79:1112-1117
27. Murray MJ, Meyer WR, Lessey BA, Oi RH, DeWire RE, Fritz MA. Soy protein isolate with isoflavones does not prevent estradiol-induced endometrial hyperplasia in postmenopausal women: a pilot trial. Menopause 2003;10:456-464
28. Bandera EV, Kushi LH, Olson SH, Chen WY, Muti P. Alcohol consumption and endometrial cancer: some unresolved issues. Nutr Cancer 2003;45:24-29
29. Rinaldi S, Peeters PH, Bezemer ID, et al. Relationship of alcohol intake and sex steroid concentrations in blood in pre- and post-menopausal women: the European Prospective Investigation into Cancer and Nutrition. Cancer Causes Control 2006;17:1033-1043
30. Loerbroks A, Schouten LJ, Goldbohm RA, van den Brandt PA. Alcohol consumption, cigarette smoking, and endometrial cancer risk: results from the Netherlands Cohort Study. Cancer Causes Control 2007;18:551-560
31. Fedirko V, Jenab M, Rinaldi S, et al. Alcohol drinking and endometrial cancer risk in the European Prospective Investigation into Cancer and Nutrition (EPIC) study. Ann Epidemiol 2013;23:93-98