Dietary Phytoestrogens and Bone Metabolism

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010686
First received: February 2, 2001
Last updated: August 17, 2006
Last verified: August 2006

February 2, 2001
August 17, 2006
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Complete list of historical versions of study NCT00010686 on ClinicalTrials.gov Archive Site
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Dietary Phytoestrogens and Bone Metabolism
Dietary Phytoestrogens and Bone Metabolism

The purpose of this study is to determine whether dietary phytoestrogens are an effective alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss.

Osteoporosis in postmenopausal women is one of the most important public health challenges of our time. With millions of women affected and billions of dollars being spent for its complications, we need to develop effective approaches to this disease. Postmenopausal women are at particular risk because the loss of estrogen associated with the menopause leads to bone loss of much greater magnitude than one would expect on the basis of age alone. Estrogen replacement therapy, a logical and effective therapeutic approach, has been associated with serious concerns about adverse events and, thus, limited use. The recent development of selective estrogen receptor modulators (SERMS) may help if they continue to show promise. Interest in natural sources of estrogenic substances to prevent postmenopausal bone loss is an expected outgrowth of the general interest in alternative medicinals for a wide variety of human disorders. Concerns about the potential for adverse consequences of the conventional use of estrogen replacement therapy, and limited knowledge about long term use of SERMS- add support to this quest. No systematic investigation of the role of dietary phytoestrogens on bone mass and skeletal dynamics has yet been conducted. With the dramatic increase in interest in these sources of estrogenic activity, it is important for us to determine whether these agents are efficacious. Otherwise, this field will be plagued for years to come by incomplete, anecdotal and scientifically poorly documented actions of these agents on bone metabolism. It is our expectation that this study will begin to provide the documentary information that the field so clearly needs. The rationale for exploring the potential for phytoestrogens in the maintenance of skeletal health in postmenopausal women is clear and compelling.

Women will be randomly assigned to one of three healthy eating plans and, over the course of the year-long study, will learn to choose and cook foods to help optimize health as they go through menopause and beyond.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Osteoporosis
Drug: Dietary Phytoestrogens
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2005
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Inclusion Criteria:

  • Postmenopausal
  • Weight within 90% to 120% of ideal body weight
  • 12 or more months since last menstrual period
  • New York Metro Area resident

Exclusion Criteria:

  • History of cancer, diabetes, or heart disease
  • Smoker
Female
50 Years to 72 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010686
P50 AT000090-01P2, P50 AT000090-01
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Dr. John P. Bilezikian Columbia University
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP