Bone Response to Soy Isoflavones in Women (SIRBL)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Manju B. Reddy, Iowa State University
ClinicalTrials.gov Identifier:
NCT00043745
First received: August 13, 2002
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

This study will provide valuable data on whether soy isoflavones impact bone loss in postmenopausal women. The study will help clarify potential mechanisms and contribute to our understanding of isoflavones as an alternative to traditional hormone therapy.


Condition Intervention Phase
Osteopenia
Osteoporosis
Dietary Supplement: Soy isoflavones
Dietary Supplement: Extract tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bone Response to Soy Isoflavones in Women

Resource links provided by NLM:


Further study details as provided by Iowa State University:

Primary Outcome Measures:
  • Lumbar spine bone mineral density [ Time Frame: Year 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proximal femur bone mineral density [ Time Frame: Year 3 ] [ Designated as safety issue: Yes ]

Enrollment: 224
Study Start Date: March 2003
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive moderate dose soy isoflavone (80 mg/day) tablets, extracted from soy protein
Dietary Supplement: Soy isoflavones
Soy isoflavones extracted from soy protein, compressed into tablets; three tablets taken daily
Experimental: 2
Participants will receive high dose soy isoflavone (120 mg/day) tablets, extracted from soy protein
Dietary Supplement: Soy isoflavones
Soy isoflavones extracted from soy protein, compressed into tablets; three tablets taken daily
Placebo Comparator: 3
Participants will receive soy extract devoid of isoflavones to serve as placebo
Dietary Supplement: Extract tablets
Extract from soy protein, but devoid of isoflavones; three tablets taken once daily

Detailed Description:

Soy protein, rich in isoflavones (estrogen-like compounds), has been shown to prevent bone loss in ovariectomized rats. Short-term preliminary study results in perimenopausal women suggest a bone-sparing effect. Great interest in isoflavones as an alternative to hormone replacement therapy has emerged, yet the long-term efficacy of isoflavones on bone in humans is unknown. Our objective is to determine the three-year efficacy of isoflavone-rich soy extract in attenuating bone loss in postmenopausal women. The central hypothesis is that soy isoflavones will attenuate bone loss in these women by maintaining bone formation, which is modulated by growth factors and isoflavone metabolism. The rationale for this research is that current hormone therapy is fraught with adverse side effects, resulting in non-compliance. This randomized, double-blind, placebo-controlled clinical trial will examine the effects of two doses (80 or 120 mg daily) of isoflavone-rich soy extract on bone in non-osteoporotic postmenopausal women (N=234). The specific aims of this study are: 1) to determine the bone-preserving effects of isoflavones on lumbar spine bone mineral density (BMD); 2) to relate treatment-induced changes in BMD to changes in biochemical markers of bone turnover; 3) to identify potential mechanisms by which isoflavones prevent or modulate bone loss by measuring endogenous estrogens, sex hormone-binding globulin, insulin-like growth factor-I (IGF-I), urinary minerals, serum 25(OH)vitamin D, plasma isoflavones and their metabolites, and customary intake of isoflavone-containing soy; and, 4) to ascertain the safety of isoflavone-rich soy extract. Postmenopausal women will be recruited at two sites (117 at Iowa, 117 at California). Random effects repeated measures analyses will be used to characterize change in BMD as the primary outcome, estimate treatment-induced effects, and depict change in markers of bone turnover in relation to BMD change. We will use intent-to-treat for the primary test, but also account for potential modulators (reproductive hormones, IGF-I, plasma isoflavones) that affect bone, as indicated in specific aim 3.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Early postmenopausal (i.e., no menses during past 12 months) women, with an upper limit of 10 years since their last cycle
  • Natural menopause (i.e., no hysterectomies or oophorectomies)
  • Body mass index (BMI) > 20 and < 30

Exclusion Criteria:

  • Current or previous (within 12 months) use of hormone replacement therapy, hormonal contraceptives, estrogens, or progestogens
  • Current use of pharmacologic agents, such as selective estrogen-receptor modulators (SERMs) (e.g., raloxifene or tamoxifen) or anti-resorptive agents (e.g., alendronate or calcitonin), herbal therapies that may have estrogenic effects (e.g., herbimycin, tryphostins), or cigarettes
  • Strict vegans (but will include lacto-ovo-, lacto-, and ovo-vegetarians)
  • Metabolic bone disease, renal disease, history of urolithiasis, cancer, cardiovascular disease, diabetes mellitus, respiratory disease, gastrointestinal disease, liver disease, or other chronic diseases
  • First-degree relative with breast cancer
  • Lumbar spine BMD >= -1.5 standard deviations (SD) below mean (high-risk for osteoporosis) and BMD >= +1.0 SD above mean
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043745

Locations
United States, California
USDA/ARS/WHNRC University of California-Davis
Davis, California, United States, 95616
United States, Iowa
Iowa State University
Ames, Iowa, United States, 50011
Sponsors and Collaborators
Iowa State University
Investigators
Principal Investigator: D. Lee Alekel, PhD Iowa State University
  More Information

No publications provided by Iowa State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Manju B. Reddy, Professor, Iowa State University
ClinicalTrials.gov Identifier: NCT00043745     History of Changes
Other Study ID Numbers: R01 AR46922, R01AR046922, NIAMS-073
Study First Received: August 13, 2002
Last Updated: February 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Iowa State University:
soy
isoflavones
alternative hormone therapy
bone loss

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 24, 2014