Dietary Phytoestrogens and Bone Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00010686
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : August 18, 2006
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Dietary Phytoestrogens Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Dietary Phytoestrogens and Bone Metabolism
Study Completion Date : December 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00010686

United States, New York
Columbia University/Health Science Division
New York, New York, United States, 10032
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Dr. John P. Bilezikian Columbia University Identifier: NCT00010686     History of Changes
Obsolete Identifiers: NCT00009360
Other Study ID Numbers: P50AT000090-01P2 ( U.S. NIH Grant/Contract )
P50AT000090-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2001    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs