Phase 3
Completed N=248
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
Source: ClinicalTrials.gov NCT00076050 ↗Enrolled (actual)
248
Serious AEs
4.8%
Results posted
Dec 2016
Primary outcomePrimary: Change From Baseline in Bone Mineral Density — 1.146; 1.132 g/cm2
◆ Published Evidence
Highly cited
179citations · ~12 / year
Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind 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.
Linked Publications
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Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Bone Mineral Density |
1.146; 1.132 | — |
| SECONDARY Changes in Women's Health Questionnaire Score |
-0.73; -0.34 | — |
| SECONDARY Change in Vaginal Maturation Value |
0.20; -1.78 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00076050) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.