Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms (SPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00076050
Recruitment Status : Completed
First Posted : January 14, 2004
Results First Posted : December 6, 2016
Last Update Posted : December 6, 2016
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Silvina Levis, MD, University of Miami

Brief 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.

Condition or disease Intervention/treatment Phase
Menopause Osteoporosis Osteopenia Dietary Supplement: Soy isoflavones Dietary Supplement: Placebo Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Bone Sparing Effects of Soy Phytoestrogens in Menopause
Study Start Date : September 2003
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: 1
Participants will receive a 200-mg dose of soy isoflavones daily over 2 years.
Dietary Supplement: Soy isoflavones
Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.

Placebo Comparator: 2
Participants will receive placebo daily over 2 years.
Dietary Supplement: Placebo
Placebo soy isoflavones

Primary Outcome Measures :
  1. Change From Baseline in Bone Mineral Density [ Time Frame: baseline and 2 years ]

Secondary Outcome Measures :
  1. Changes in Women's Health Questionnaire Score [ Time Frame: baseline and 2 years ]
    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.

  2. Change in Vaginal Maturation Value [ Time Frame: baseline and 2 years ]
    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.

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00076050

United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Silvina Levis, MD University of Miami

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Silvina Levis, MD, Professor, University of Miami Identifier: NCT00076050     History of Changes
Other Study ID Numbers: R01AR048932 ( U.S. NIH Grant/Contract )
R01AR048932 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2004    Key Record Dates
Results First Posted: December 6, 2016
Last Update Posted: December 6, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs