Completed
SPARE

Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms

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What is being tested

Soy isoflavones

+ Placebo
Dietary Supplement
Who is being recruted

Menopause

+ Osteoporosis
+ Osteopenia
From 45 to 60 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 3
Interventional
Study Start: September 2003

See protocol details

Summary

Principal SponsorUniversity of Miami
Last updated: December 6, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleBone Sparing Effects of Soy Phytoestrogens in Menopause 
Principal SponsorUniversity of Miami
Last updated: December 6, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
248 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 45 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Menopause
Osteoporosis
Osteopenia
Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Participants will receive a 200-mg dose of soy isoflavones daily over 2 years.
Group II
Placebo
Participants will receive placebo daily over 2 years.
Study Objectives
Primary Objectives

Secondary Objectives

This self-administered questionnaire contains 23 items, distributed among 6 factors: anxiety and depressed mood (7 items), well-being (4 items), somatic symptoms (5 items), memory and concentration (3 items), vasomotor symptoms (2 items) and sleep problems (2 items). The instrument has a structured format and the response choices consist of 4-point Likert scales ('yes definitely' to 'no, not at all'). Item scores are collapsed into a dichotomous scale, where higher scores indicate a greater level of symptomatology or difficulty; i.e., if the response is 1 or 2 (positive response), the score = 1; if the response is 3 or 4 (negative response), the score is 0. Results can be reported as a total score, where the range is 0-23, but also for each dimension. Thus, the ranges of the subscales are: for anxiety and mood 0-7, for well-being 0-4, somatic symptoms 0-5, memory and concentration 0-3, vasomotor symptoms 0-2 and sleep problems 0-2.

The Vaginal Maturation Value (VMV) describes the proportion of the three vaginal epithelial cell types (parabasal, intermediate and superficial) obtained from a swab of the vaginal walls. The changes in the proportion of each type of cells reflects the degree of exposure to estrogen of the vaginal epithelium. The VMV lists the percentage of each type of cell appearing on the smear, with the total of all three values equaling 100%. The index is read from left to right; i.e. VMI of 5/40/55 represents 5% parabasal cells, 40% intermediate cells and 55% superficial cells. Exposure to estrogens results in some parabasal cells, a greater proportion of intermediate cells and few superficial cells.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Miami School of MedicineMiami, United StatesSee the location
CompletedOne Study Center