Evidence map›Paper›PMID 19906801›Full record

Trial reportThe American journal of clinical nutrition2010

The soy isoflavones for reducing bone loss (SIRBL) study: a 3-y randomized controlled trial in postmenopausal women.

D Lee Alekel, Marta D Van Loan, Kenneth J Koehler, Laura N Hanson, Jeanne W Stewart, Kathy B Hanson, Mindy S Kurzer, C Theodore Peterson

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of clinical nutrition, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00043745 (Bone Response to Soy Isoflavones in Women), which is not on this map. Cited by 45 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 6 pooled it
11.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00043745 phase2completednot on this map

Bone Response to Soy Isoflavones in Women

TypeinterventionalSponsorIowa State UniversityRan2003Enrolled224ConditionsOsteopenia, OsteoporosisArmsSoy isoflavones, Extract tablets
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 6 syntheses or guidelines pooled it, 157 citations in OpenAlex.

  1. Isoflavone intervention and its impact on bone mineral density in postmenopausal women: a systematic review and meta-analysis of randomized controlled trials.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2024
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. The effect of soy isoflavone on bone mineral density in postmenopausal Taiwanese women with bone loss: a 2-year randomized double-blind placebo-controlled study.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2012
    Trial
  13. Trial
  14. The soy isoflavones for reducing bone loss study: 3-yr effects on pQCT bone mineral density and strength measures in postmenopausal women.Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry
    Trial
  15. Contribution of serum inflammatory markers to changes in bone mineral content and density in postmenopausal women: a 1-year investigation.Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry
    Trial
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

D Lee AlekelNutrition and Wellness Research Center, Department of Food Science and Human Nutrition, Iowa State University, Ames, IA 50010-8281, USA. alekel@iastate.edu
Marta D Van Loan
Kenneth J Koehler
Laura N Hanson
Jeanne W Stewart
Kathy B Hanson
Mindy S Kurzer
C Theodore Peterson
Iowa State University · USFood and Nutrition Service · USUniversity of California, Davis · US

Funding

UC DAVIS CLINICAL AND TRANSLATIONAL SCIENCE CENTER: BPCAUL1RR024146 · NCRR · UNIVERSITY OF CALIFORNIA AT DAVIS · PI BERGLUND, LARS F · 2006 to 2011
$27.0M
Bone Response to Soy Isoflavones in WomenR01AR046922 · NIAMS · IOWA STATE UNIVERSITY · PI ALEKEL, D. LEE · 2002 to 2008
$3.1M
NCRR NIH HHS UL1 RR024146NIAMS NIH HHS R01 AR046922
6 · The paper itself

Abstract

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

objectiveWe 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.

designOur 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.

resultsAnalysis 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.

conclusionOur 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.

Indexed as

AgedBone DensityCalciumCaliforniaCholecalciferolDouble-Blind MethodFemaleGlycine maxHumansIowaIsoflavonesLife StyleMiddle AgedOsteoporosisPatient SelectionPostmenopauseCalciumCholecalciferolIsoflavonesTablets

Identifiers

PMID19906801
PMCPMC2793109
OpenAlexW2114341935

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.