Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms

Osteoporosis Clinical Trial

— SPARE  

Official title:

Bone Sparing Effects of Soy Phytoestrogens in Menopause

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00076050
• Other study ID #: R01AR048932
• Secondary ID: NIAMS-114SPARE
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 13, 2004
• Last updated: April 8, 2009
• Start date: September 2003
• Est. completion date: June 2009

Study information

• Verified date: April 2009
• Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recently gone through menopause.

Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally occurring spinal bone loss and improve biological and other emotional changes of menopause.

Description:

The risks of bone loss and osteoporosis increase significantly after menopause. Although hormone therapy (HT) can spare menopausal women from bone loss and other menopausal symptoms, Women's Health Initiative (WHI) findings indicate significant potential health risks associated with HT. This has prompted women to switch from HT to naturally occurring compounds similar to estrogen, such as those derived from soy, in the hope that estrogens from plant sources can provide benefits while sparing adverse effects caused by prescribed estrogens. However, the long-term efficacy and safety of plant estrogens are unknown. This study will evaluate the effectiveness of treatment using purified soy isoflavones, a dietary source of phytoestrogens, in preventing bone loss, menopausal symptoms, and other changes associated with estrogen deficiency in young menopausal women. The "Soy Phytoestrogens As Replacement Estrogen (SPARE)" study will provide a foundation of knowledge from which menopausal women and their doctors can begin to make more informed decisions regarding HT and other treatment options.

Enrollment into the study will occur over 3 years, with each participant taking part in the study for a total of 2 years. Participants will be randomly assigned to one of two groups; the first group will receive a 200 mg dose of soy isoflavones daily and the second group will receive placebo daily. There will be 10 study visits: screening, study entry, randomization at Month 1, six follow-up visits at Months 2, 4, 8, 12, 16, 20, and a final visit at the end of active participation at Month 24. At each study visit, participants will have blood drawn, provide urine samples, answer questionnaires, and have mammograms and bone density tests.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

Inclusion Criteria

• Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L

Exclusion Criteria

• Treatment with estrogens, progesterone, raloxifene, or tamoxifen

• Treatment with bisphosphonates, calcitonin, fluoride, or systemic corticosteroids

• Use of soy/herbal supplements, including DHEA, within 3 months prior to study entry

• Use of antibiotics in the month prior to study entry

• Use of prescription medication to treat hot flashes

• Chemical menopause, including post-chemotherapy

• Hyperthyroidism

• Hypothyroidism

• Uncontrolled diabetes

• Malabsorption syndromes or other chronic diseases

• Body mass index (BMI) less than 20 or greater than 32

• Bone mineral density (BMD) T-score below -2.0 in lumbar spine or femoral neck

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopause
• Osteopenia
• Osteoporosis

Intervention

Dietary Supplement:
• Soy isoflavones
Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.
• Placebo
Placebo soy isoflavones

Locations

Country	Name	City	State
United States	University of Miami School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of a daily dose of purified soy isoflavone in preventing the rapid spinal bone loss occurring in early menopause		2 years	No
Secondary	Effectiveness in preventing hot flashes and changes in vaginal cytology, lipids, and binding globulins		yearly over 2 years	No
Secondary	prevention of deterioration of general health-related quality of life and emotional health status generally occurring in early menopause		over 2 years	No