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Isoflavones for Promoting Calcium Absorption and Preventing Bone Loss in Post Menopausal Women

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ClinicalTrials.gov Identifier: NCT00244907
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Berdine Martin, Purdue University

Brief Summary:
Estrogen is a hormone that helps prevent calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may lead to bone loss and possibly osteoporosis. Isoflavones are natural compounds found in soy plants that may help provide protection against bone loss. This study will evaluate the effect of soy isoflavones on calcium absorption and bone loss in post menopausal women.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Dietary Supplement: Genistein vs Risedronate Phase 1

Detailed Description:

Estrogen is a hormone that activates bone-forming cells and prevents calcium loss and bone breakdown. During menopause, estrogen levels decrease. Insufficient amounts of estrogen may accelerate bone breakdown and inhibit the body's ability to create new bone, thereby leading to bone loss and possibly osteoporosis. Various treatments have been developed to decrease bone loss in post-menopausal women. Actonel, for example, is an FDA-approved drug used to help prevent bone loss.

Phytoestrogens are plant compounds with a structure similar to estrogen. They have also been shown to help reduce the negative effects of menopause. Isoflavones are a particular type of phytoestrogens that are found in soy plants and may act like estrogen in providing possible protection against bone loss. This study will compare the effects of isoflavones (including genistein, a type of isoflavone) versus Actonel on calcium absorption and bone loss in post-menopausal women.

Participants in this double-blind cross-over study will first complete a screening process, which will include answering questions about their health habits, medical history, physical activity, and food patterns. They will then eat one soy bar daily for 3 days. On Day 4, a urine sample will be taken to assess their ability to metabolize phytoestrogen from soybeans. Participants will be randomly assigned to a specific treatment order. Participants will receive 1-4 unique soy isoflavones, followed by Actonel. Treatment phases will be separated by a 50-day washout period. All participants will also take calcium and vitamin D supplements throughout the study. Assessments will include bone density measurements, calcium absorption tests, and blood and urine tests. The study will last approximately 2.5 years.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Metabolism and Bone Health
Study Start Date : January 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Menopause

Arm Intervention/treatment
Active Comparator: Genistein vs. Risedronate
Healthy post menopausal women who have been dosed with Ca41. Intervention, 100 mg Gensitein from soy protein isolate for 50 days. After a 50 day washout risedronate (Actonel- 5mg per day) for 50 days
Dietary Supplement: Genistein vs Risedronate
Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)
Other Name: Actonel

Active Comparator: Genistein dose and source
Healthy post menopausal women will consume 5 products containing varying quantities of genistein from different sources for 50 days each in a randomized order. Each intervention period is separated by a 50 day washout period. Intervention: A) 50 mg genistein from soy protein isolate, B) 100 mg genistein from soy protein isolate, C)50 mg genistein from Novasoy, D) 100 mg genistein from Novasoy, E) 100 ng genistein from 50% Novasoy and 50% soy protein isolate
Dietary Supplement: Genistein vs Risedronate
Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)
Other Name: Actonel




Primary Outcome Measures :
  1. Urinary markers of bone resorption; measured at the end of each treatment phase [ Time Frame: Every 50 days ]

Secondary Outcome Measures :
  1. Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase [ Time Frame: Every 50 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 4 years post-menopausal

Exclusion Criteria:

  • Not currently taking estrogen replacement therapy or undergoing any treatment for osteoporosis
  • Diagnosis of breast cancer
  • Results of mammogram suggesting breast cancer

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 ClinicalTrials.gov identifier (NCT number): NCT00244907


Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Connie M. Weaver, PhD Purdue University

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Berdine Martin, Research Scientist, Nutrition Science, Purdue University
ClinicalTrials.gov Identifier: NCT00244907     History of Changes
Other Study ID Numbers: P50AT000477-06 ( U.S. NIH Grant/Contract )
P50AT000477-06 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

Keywords provided by Berdine Martin, Purdue University:
Bone Resorption
Phytoestrogens
Calcium
Genistein
Equol

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Risedronate Sodium
Etidronic Acid
Genistein
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists