Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: A randomized, double-blind trial

Silvina Levis, Nancy Strickman-Stein, Parvin Ganjei-Azar, Ping Xu, Daniel R. Doerge, Jeffrey Krischer

Research output: Contribution to journalArticle

124 Citations (Scopus)

Abstract

Background: Concerns regarding the risk of estrogen replacement have resulted in a significant increase in the use of soy products by menopausal women who, despite the lack of evidence of the efficacy of such products, seek alternatives to menopausal hormone therapy. Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms. Methods: The study design was a single-center, randomized, placebo-controlled, double-blind clinical trial conducted from July 1, 2004, through March 31, 2009. Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were randomly assigned, in equal proportions, to receive daily soy isoflavone tablets, 200 mg, or placebo. The primary outcome was changes in bone mineral density in the lumbar spine, total hip, and femoral neck at the 2-year follow-up. Secondary outcomes included changes in menopausal symptoms, vaginal cytologic characteristics, N-telopeptide of type I bone collagen, lipids, and thyroid function. Results: After 2 years, no significant differences were found between the participants receiving soy tablets (n=122) and those receiving placebo (n=126) regarding changes in bone mineral density in the spine (-2.0% and -2.3%, respectively), the total hip (-1.2% and -1.4%, respectively), or the femoral neck (-2.2% and -2.1%, respectively). A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group. No significant differences were found between groups in other outcomes. Conclusions: In this population, the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms. Trial Registration: clinicaltrials.gov Identifier: NCT00076050.

Original languageEnglish
Pages (from-to)1363-1369
Number of pages7
JournalArchives of Internal Medicine
Volume171
Issue number15
DOIs
StatePublished - Aug 18 2011

Fingerprint

Isoflavones
Tablets
Bone Density
Hip
Bone and Bones
Spine
Femur Neck
Placebos
Hot Flashes
Estrogen Replacement Therapy
Constipation
Menopause
Collagen Type I
Thyroid Gland
Clinical Trials
Hormones
Lipids
Control Groups
Population
Therapeutics

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms : A randomized, double-blind trial. / Levis, Silvina; Strickman-Stein, Nancy; Ganjei-Azar, Parvin; Xu, Ping; Doerge, Daniel R.; Krischer, Jeffrey.

In: Archives of Internal Medicine, Vol. 171, No. 15, 18.08.2011, p. 1363-1369.

Research output: Contribution to journalArticle

Levis, Silvina ; Strickman-Stein, Nancy ; Ganjei-Azar, Parvin ; Xu, Ping ; Doerge, Daniel R. ; Krischer, Jeffrey. / Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms : A randomized, double-blind trial. In: Archives of Internal Medicine. 2011 ; Vol. 171, No. 15. pp. 1363-1369.
@article{48ce0c8144aa4be085a2e76393f6fea3,
title = "Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: A randomized, double-blind trial",
abstract = "Background: Concerns regarding the risk of estrogen replacement have resulted in a significant increase in the use of soy products by menopausal women who, despite the lack of evidence of the efficacy of such products, seek alternatives to menopausal hormone therapy. Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms. Methods: The study design was a single-center, randomized, placebo-controlled, double-blind clinical trial conducted from July 1, 2004, through March 31, 2009. Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were randomly assigned, in equal proportions, to receive daily soy isoflavone tablets, 200 mg, or placebo. The primary outcome was changes in bone mineral density in the lumbar spine, total hip, and femoral neck at the 2-year follow-up. Secondary outcomes included changes in menopausal symptoms, vaginal cytologic characteristics, N-telopeptide of type I bone collagen, lipids, and thyroid function. Results: After 2 years, no significant differences were found between the participants receiving soy tablets (n=122) and those receiving placebo (n=126) regarding changes in bone mineral density in the spine (-2.0{\%} and -2.3{\%}, respectively), the total hip (-1.2{\%} and -1.4{\%}, respectively), or the femoral neck (-2.2{\%} and -2.1{\%}, respectively). A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group. No significant differences were found between groups in other outcomes. Conclusions: In this population, the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms. Trial Registration: clinicaltrials.gov Identifier: NCT00076050.",
author = "Silvina Levis and Nancy Strickman-Stein and Parvin Ganjei-Azar and Ping Xu and Doerge, {Daniel R.} and Jeffrey Krischer",
year = "2011",
month = "8",
day = "18",
doi = "10.1001/archinternmed.2011.330",
language = "English",
volume = "171",
pages = "1363--1369",
journal = "JAMA Internal Medicine",
issn = "2168-6106",
publisher = "American Medical Association",
number = "15",

}

TY - JOUR

T1 - Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms

T2 - A randomized, double-blind trial

AU - Levis, Silvina

AU - Strickman-Stein, Nancy

AU - Ganjei-Azar, Parvin

AU - Xu, Ping

AU - Doerge, Daniel R.

AU - Krischer, Jeffrey

PY - 2011/8/18

Y1 - 2011/8/18

N2 - Background: Concerns regarding the risk of estrogen replacement have resulted in a significant increase in the use of soy products by menopausal women who, despite the lack of evidence of the efficacy of such products, seek alternatives to menopausal hormone therapy. Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms. Methods: The study design was a single-center, randomized, placebo-controlled, double-blind clinical trial conducted from July 1, 2004, through March 31, 2009. Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were randomly assigned, in equal proportions, to receive daily soy isoflavone tablets, 200 mg, or placebo. The primary outcome was changes in bone mineral density in the lumbar spine, total hip, and femoral neck at the 2-year follow-up. Secondary outcomes included changes in menopausal symptoms, vaginal cytologic characteristics, N-telopeptide of type I bone collagen, lipids, and thyroid function. Results: After 2 years, no significant differences were found between the participants receiving soy tablets (n=122) and those receiving placebo (n=126) regarding changes in bone mineral density in the spine (-2.0% and -2.3%, respectively), the total hip (-1.2% and -1.4%, respectively), or the femoral neck (-2.2% and -2.1%, respectively). A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group. No significant differences were found between groups in other outcomes. Conclusions: In this population, the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms. Trial Registration: clinicaltrials.gov Identifier: NCT00076050.

AB - Background: Concerns regarding the risk of estrogen replacement have resulted in a significant increase in the use of soy products by menopausal women who, despite the lack of evidence of the efficacy of such products, seek alternatives to menopausal hormone therapy. Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms. Methods: The study design was a single-center, randomized, placebo-controlled, double-blind clinical trial conducted from July 1, 2004, through March 31, 2009. Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were randomly assigned, in equal proportions, to receive daily soy isoflavone tablets, 200 mg, or placebo. The primary outcome was changes in bone mineral density in the lumbar spine, total hip, and femoral neck at the 2-year follow-up. Secondary outcomes included changes in menopausal symptoms, vaginal cytologic characteristics, N-telopeptide of type I bone collagen, lipids, and thyroid function. Results: After 2 years, no significant differences were found between the participants receiving soy tablets (n=122) and those receiving placebo (n=126) regarding changes in bone mineral density in the spine (-2.0% and -2.3%, respectively), the total hip (-1.2% and -1.4%, respectively), or the femoral neck (-2.2% and -2.1%, respectively). A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group. No significant differences were found between groups in other outcomes. Conclusions: In this population, the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms. Trial Registration: clinicaltrials.gov Identifier: NCT00076050.

UR - http://www.scopus.com/inward/record.url?scp=80051628660&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80051628660&partnerID=8YFLogxK

U2 - 10.1001/archinternmed.2011.330

DO - 10.1001/archinternmed.2011.330

M3 - Article

C2 - 21824950

AN - SCOPUS:80051628660

VL - 171

SP - 1363

EP - 1369

JO - JAMA Internal Medicine

JF - JAMA Internal Medicine

SN - 2168-6106

IS - 15

ER -