Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety, Efficacy, and Optimal Dosage of Soy Isoflavones to Prevent Osteoporosis
Brief Summary: The purpose of this study is to determine whether soy isoflavone supplementation is safe and effective to prevent bone loss in postmenopausal women.


Options:
A: Inclusion Criteria:

* female
* age 45 - 55
* peri- or post-menopausal
* moderate to severe vasomotor symptoms
* normal thyroid stimulating hormone
* proof of normal mammogram within past 2 years

Exclusion Criteria:

* use of HT or oral contraceptives within past 3 months
* use of herbs or alternative or complementary medicines for vasomotor symptoms within past 1 month
* medical history of contraindications to HT
* bone mineral density greater than 2 standard deviations below age specific mean
* bilateral oophorectomy
* current use of tamoxifen, raloxifene, bisphosphonates, cholesterol-lowering medications, prescription blood-thinners, or oral steroids
* pregnant or planning to become pregnant
* allergy to soybeans or soy protein
* unable to swallow pills
* current participation in another investigational drug trial
* intention to move out of area in the next 12 months
* non-compliance with procedures involved in screening and run-in trial
B: Inclusion Criteria:

* Menopausal women with intact uterus
* Must be experiencing hot flashes
* No menstrual periods for at least 6 months and no longer than 3 years
* Non-smoker
* Must have intact uterus (no hysterectomy)

Exclusion Criteria:

* Contraindications for hormone replacement therapy
* Diabetes mellitus
* Pregnancy or breast-feeding
* Obese (BMI \>35 excluded)
* History of endometrial hyperplasia/neoplasia/malignancy
* History of breast or reproductive cancer
* History of severe recurrent depression, or severe psychiatric disturbance
* History of stroke/CVA, severe varicose veins, sickle cell anemia, myocardial infarction (heart attack), or arrhythmia (rhythm disturbance of the heart)
* History of abnormal vaginal bleeding of unknown cause
* Untreated or uncontrolled high blood pressure/hypertension
* Use of any medication or supplement containing estrogen, progestin, SERM, St. John's Wort, bisphosphonates, or phytoestrogens
* History of hormone-associated migraines
* History of deep vein thrombosis (blood clots), thrombophlebitis, or thromboembolic disorders
* Participation in a clinical trial within 30 days
* Abnormal endometrial biopsy or mammogram
* Abnormal transvaginal ultrasound defined as \>7mm thickness
* Vegan
C: Postmenopausal women ages 50 to 79.
D: Inclusion Criteria:

* Must be able to swallow the pills
* No menses for 12 months
* Blood follicle stimulating hormone great than 30 IU/mL
* Lumbar spine bone mineral density t-score equal to or greater than -1.5

Exclusion Criteria:

* Strict vegetarians
* Current or recent smokers (within last five years)
* Abnormal screening mammogram, Pap smear and blood chemistries
* Clinical diagnosis of osteoporosis, spine and/or hip fracture, cancer, liver, kidney, gallbladder and heart disease
* Clinical diagnosis of psychiatric disorder
* Any allergic reactions to soy products
* Current treatment with bisphosphonates, calcitonin, fluoride, corticosteroids, tamoxifen, raloxifene, HRT, premarin, farestron and letrozole
* Current usage of black cohosh, blue cohosh, dong quai, Caltrate 600+Soy, Estroven, ginseng, Healthy Women, Natural Estrogen, Opti-Soy, PhytoFem, Probalance, Promensil, Remifemin, Rimostil and Trinovin

Answer: D