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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

Tracking Information
First Submitted Date  ICMJE October 25, 2005
First Posted Date  ICMJE October 27, 2005
Last Update Posted Date May 4, 2018
Study Start Date  ICMJE January 2006
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2008)
Urinary markers of bone resorption; measured at the end of each treatment phase [ Time Frame: Every 50 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
Urinary markers of bone resorption; measured at the end of each treatment phase
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2008)
Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase [ Time Frame: Every 50 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Isoflavones for Promoting Calcium Absorption and Preventing Bone Loss in Post Menopausal Women
Official Title  ICMJE Metabolism and Bone Health
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Osteoporosis
  • Osteopenia
Intervention  ICMJE Dietary Supplement: Genistein vs Risedronate
Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)
Other Name: Actonel
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: Genistein vs Risedronate
  • 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
    Intervention: Dietary Supplement: Genistein vs Risedronate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2014)
23
Original Enrollment  ICMJE
 (submitted: October 25, 2005)
20
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00244907
Other Study ID Numbers  ICMJE P50AT000477-06( U.S. NIH Grant/Contract )
P50AT000477-06 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Berdine Martin, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE
  • National Center for Complementary and Integrative Health (NCCIH)
  • Office of Dietary Supplements (ODS)
Investigators  ICMJE
Principal Investigator: Connie M. Weaver, PhD Purdue University
PRS Account Purdue University
Verification Date May 2018

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