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
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Dietary Phytoestrogens
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Dietary Phytoestrogens and Bone Metabolism

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   50 Years to 72 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00010686

Locations
United States, New York
Columbia University/Health Science Division
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Dr. John P. Bilezikian Columbia University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00010686     History of Changes
Obsolete Identifiers: NCT00009360
Other Study ID Numbers: P50 AT000090-01P2, P50 AT000090-01
Study First Received: February 2, 2001
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 18, 2014