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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
  Purpose

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 Intervention Phase
Menopause
Osteoporosis
Osteopenia
Dietary Supplement: Soy isoflavones
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Bone Sparing Effects of Soy Phytoestrogens in Menopause

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Change From Baseline in Bone Mineral Density [ Time Frame: baseline and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Women's Health Questionnaire Score [ Time Frame: baseline and 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 248
Study Start Date: September 2003
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076050

Locations
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)
Investigators
Principal Investigator: Silvina Levis, MD University of Miami
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Silvina Levis, MD, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00076050     History of Changes
Other Study ID Numbers: R01AR048932  NIAMS-114  SPARE 
Study First Received: January 13, 2004
Results First Received: June 26, 2013
Last Updated: October 12, 2016
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on December 06, 2016