Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 12:46 PM
Study NCT ID:
NCT00076050
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2004-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
Bone Sparing Effects of Soy Phytoestrogens in Menopause
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARE
Brief 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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AR048932 | NIH | None | https://reporter.nih.gov/quic… | View |
| NIAMS-114 | None | None | View | |
| SPARE | None | None | View |