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

Osteoporosis Clinical Trial

Official title:

Metabolism and Bone Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244907
• Other study ID #: P50AT000477-06
• Secondary ID: P50AT000477-06
• Status: Completed
• Phase: Phase 1
• Start date: January 2006
• Est. completion date: May 2010

Study information

• Verified date: May 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis

Intervention

Dietary Supplement:
• Genistein vs Risedronate
Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Purdue University	National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Jackson GS, Weaver C, Elmore D. Use of accelerator mass spectrometry for studies in nutrition. Nutr Res Rev. 2001 Dec;14(2):317-34. doi: 10.1079/NRR200129. — View Citation

Spence LA, Lipscomb ER, Cadogan J, Martin B, Wastney ME, Peacock M, Weaver CM. The effect of soy protein and soy isoflavones on calcium metabolism in postmenopausal women: a randomized crossover study. Am J Clin Nutr. 2005 Apr;81(4):916-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary markers of bone resorption; measured at the end of each treatment phase		Every 50 days
Secondary	Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase		Every 50 days

External Links

•   Purdue UAB Botanicals Research Center