Isoflavones for Promoting Calcium Absorption and Preventing Bone Loss in Post Menopausal Women
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Osteoporosis Osteopenia |
Drug: Soy Phytoestrogens |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Metabolism and Bone Health |
- Urinary markers of bone resorption; measured at the end of each treatment phase [ Time Frame: Every 50 days ] [ Designated as safety issue: No ]
- Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase [ Time Frame: Every 50 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
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Drug: Soy Phytoestrogens
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Connie Weaver, PhD, Purdue University |
| ClinicalTrials.gov Identifier: | NCT00244907 History of Changes |
| Other Study ID Numbers: | P50 AT000477-06, P50AT000477-06 |
| Study First Received: | October 25, 2005 |
| Last Updated: | July 27, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Purdue University:
|
Bone Resorption Phytoestrogens Calcium Genistein Equol |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Osteoporosis 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 May 23, 2013