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OpenTrials
Completed

NCT Number: NCT00244907

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Bone Resorption Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genistein vs Risedronate

Dietary Supplement

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

Other names: Actonel

Primary outcomes

  1. Urinary markers of bone resorption; measured at the end of each treatment phase

    Time frame: Every 50 days

Secondary outcomes

  1. Serum markers of bone resorption and calcium absorption; measured at the end of each treatment phase

    Time frame: Every 50 days

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Office of Dietary Supplements (ODS)

Registry information

Official study title

Metabolism and Bone Health

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2005
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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