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

Metabolism and Bone Health

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00244907
Enrollment
23
Registered
2005-10-27
Start date
2006-01-31
Completion date
2010-05-31
Last updated
2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia, Osteoporosis

Keywords

Bone Resorption, Phytoestrogens, Calcium, Genistein, Equol

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.

Interventions

DIETARY_SUPPLEMENTGenistein vs Risedronate

Gensitein (100 gm) from soy protein isolate Risedronate (5 mg)

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Office of Dietary Supplements (ODS)
CollaboratorNIH
Purdue University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Urinary markers of bone resorption; measured at the end of each treatment phaseEvery 50 days

Secondary

MeasureTime frame
Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phaseEvery 50 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026