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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Silvina Levis, MD, University of Miami
ClinicalTrials.gov Identifier:
NCT00076050
First received: January 13, 2004
Last updated: October 12, 2016
Last verified: October 2016

January 13, 2004
October 12, 2016
September 2003
March 2009   (Final data collection date for primary outcome measure)
Change From Baseline in Bone Mineral Density [ Time Frame: baseline and 2 years ]
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Complete list of historical versions of study NCT00076050 on ClinicalTrials.gov Archive Site
  • 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.
  • 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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Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
Bone Sparing Effects of Soy Phytoestrogens in Menopause

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Menopause
  • Osteoporosis
  • Osteopenia
  • Dietary Supplement: Soy isoflavones
    Purified soy isoflavones (phytoestrogens) in tablet form tablets; 200 mg.
  • Dietary Supplement: Placebo
    Placebo soy isoflavones
  • Experimental: 1
    Participants will receive a 200-mg dose of soy isoflavones daily over 2 years.
    Intervention: Dietary Supplement: Soy isoflavones
  • Placebo Comparator: 2
    Participants will receive placebo daily over 2 years.
    Intervention: Dietary Supplement: Placebo
Levis S, Strickman-Stein N, Ganjei-Azar P, Xu P, Doerge DR, Krischer J. Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. Arch Intern Med. 2011 Aug 8;171(15):1363-9. doi: 10.1001/archinternmed.2011.330.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
248
June 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
45 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00076050
R01AR048932
R01AR048932 ( US NIH Grant/Contract Award Number )
NIAMS-114
SPARE
Yes
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Silvina Levis, MD, University of Miami
University of Miami
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Silvina Levis, MD University of Miami
University of Miami
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP