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The soy isoflavones for reducing bone loss (SIRBL) study: a 3-y randomized controlled trial in postmenopausal women.
Am J Clin Nutr. 2010 Jan; 91(1):218-30.AJ

Abstract

BACKGROUND

Our previous study indicated that soy protein with isoflavones lessened lumbar spine bone loss in midlife women.

OBJECTIVE

We examined the efficacy of isoflavones (extracted from soy protein) on bone mineral density (BMD) in nonosteoporotic postmenopausal women. We hypothesized that isoflavone tablets would spare BMD, with biological (age, body weight, serum 25-hydroxyvitamin D) and lifestyle (physical activity, dietary intake) factors modulating BMD loss.

DESIGN

Our double-blind, randomized controlled trial (36 mo) included healthy postmenopausal women (aged 45.8-65.0 y) with intent-to-treat (n = 224) and compliant (n = 208) analyses. Treatment groups consisted of a placebo control group and 2 soy isoflavone groups (80 compared with 120 mg/d); women received 500 mg calcium and 600 IU vitamin D(3). Outcomes included lumbar spine, total proximal femur, femoral neck, and whole-body BMD.

RESULTS

Analysis of variance for intent-to-treat and compliant (> or =80%) models, respectively, showed no treatment effect for spine (P = 0.46, P = 0.21), femur (P = 0.86, P = 0.46), neck (P = 0.17, P = 0.14), or whole-body (P = 0.86, P = 0.78) BMD. From baseline to 36 mo, BMD declined regardless of treatment. In intent-to-treat and compliant models, respectively, BMD decreases were as follows: spine (-2.08%, -1.99%), femur (-1.43%, -1.38%), neck (-2.56%, -2.51%), and whole body (-1.66%, -1.62%). Regression analysis (compliant model) indicated that age, whole-body fat mass, and bone resorption were common predictors of BMD change. After adjustment for these factors, 120 mg (compared with placebo) was protective (P = 0.024) for neck BMD. We observed no treatment effect on adverse events, endometrial thickness, or bone markers.

CONCLUSION

Our results do not show a bone-sparing effect of extracted soy isoflavones, except for a modest effect at the femoral neck. This trial was registered at clinicaltrials.gov as NCT00043745.

Authors+Show Affiliations

Nutrition and Wellness Research Center, Department of Food Science and Human Nutrition, Iowa State University, Ames, IA 50010-8281, USA. alekel@iastate.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

19906801

Citation

Alekel, D Lee, et al. "The Soy Isoflavones for Reducing Bone Loss (SIRBL) Study: a 3-y Randomized Controlled Trial in Postmenopausal Women." The American Journal of Clinical Nutrition, vol. 91, no. 1, 2010, pp. 218-30.
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(1):218-30.
Alekel, D. L., Van Loan, M. D., Koehler, K. J., Hanson, L. N., Stewart, J. W., Hanson, K. B., Kurzer, M. S., & Peterson, C. T. (2010). The soy isoflavones for reducing bone loss (SIRBL) study: a 3-y randomized controlled trial in postmenopausal women. The American Journal of Clinical Nutrition, 91(1), 218-30. https://doi.org/10.3945/ajcn.2009.28306
Alekel DL, 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(1):218-30. PubMed PMID: 19906801.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The soy isoflavones for reducing bone loss (SIRBL) study: a 3-y randomized controlled trial in postmenopausal women. AU - Alekel,D Lee, AU - Van Loan,Marta D, AU - Koehler,Kenneth J, AU - Hanson,Laura N, AU - Stewart,Jeanne W, AU - Hanson,Kathy B, AU - Kurzer,Mindy S, AU - Peterson,C Theodore, Y1 - 2009/11/11/ PY - 2009/11/13/entrez PY - 2009/11/13/pubmed PY - 2010/1/14/medline SP - 218 EP - 30 JF - The American journal of clinical nutrition JO - Am. J. Clin. Nutr. VL - 91 IS - 1 N2 - BACKGROUND: Our previous study indicated that soy protein with isoflavones lessened lumbar spine bone loss in midlife women. OBJECTIVE: We examined the efficacy of isoflavones (extracted from soy protein) on bone mineral density (BMD) in nonosteoporotic postmenopausal women. We hypothesized that isoflavone tablets would spare BMD, with biological (age, body weight, serum 25-hydroxyvitamin D) and lifestyle (physical activity, dietary intake) factors modulating BMD loss. DESIGN: Our double-blind, randomized controlled trial (36 mo) included healthy postmenopausal women (aged 45.8-65.0 y) with intent-to-treat (n = 224) and compliant (n = 208) analyses. Treatment groups consisted of a placebo control group and 2 soy isoflavone groups (80 compared with 120 mg/d); women received 500 mg calcium and 600 IU vitamin D(3). Outcomes included lumbar spine, total proximal femur, femoral neck, and whole-body BMD. RESULTS: Analysis of variance for intent-to-treat and compliant (> or =80%) models, respectively, showed no treatment effect for spine (P = 0.46, P = 0.21), femur (P = 0.86, P = 0.46), neck (P = 0.17, P = 0.14), or whole-body (P = 0.86, P = 0.78) BMD. From baseline to 36 mo, BMD declined regardless of treatment. In intent-to-treat and compliant models, respectively, BMD decreases were as follows: spine (-2.08%, -1.99%), femur (-1.43%, -1.38%), neck (-2.56%, -2.51%), and whole body (-1.66%, -1.62%). Regression analysis (compliant model) indicated that age, whole-body fat mass, and bone resorption were common predictors of BMD change. After adjustment for these factors, 120 mg (compared with placebo) was protective (P = 0.024) for neck BMD. We observed no treatment effect on adverse events, endometrial thickness, or bone markers. CONCLUSION: Our results do not show a bone-sparing effect of extracted soy isoflavones, except for a modest effect at the femoral neck. This trial was registered at clinicaltrials.gov as NCT00043745. SN - 1938-3207 UR - https://www.unboundmedicine.com/medline/citation/19906801/The_soy_isoflavones_for_reducing_bone_loss__SIRBL__study:_a_3_y_randomized_controlled_trial_in_postmenopausal_women_ L2 - https://academic.oup.com/ajcn/article-lookup/doi/10.3945/ajcn.2009.28306 DB - PRIME DP - Unbound Medicine ER -