Osteoporosis Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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