Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043745
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2002-08-13
Brief Title:
Bone Response to Soy Isoflavones in Women
Sponsor:
Iowa State University
Organization:
Iowa State University
Study Overview
Official Title:
Bone Response to Soy Isoflavones in Women
Status:
COMPLETED
Status Verified Date:
2013-02
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:
SIRBL
Brief Summary:
This study will provide valuable data on whether soy isoflavones impact bone loss in postmenopausal women The study will help clarify potential mechanisms and contribute to our understanding of isoflavones as an alternative to traditional hormone therapy
Detailed Description:
Soy protein rich in isoflavones estrogen-like compounds has been shown to prevent bone loss in ovariectomized rats Short-term preliminary study results in perimenopausal women suggest a bone-sparing effect Great interest in isoflavones as an alternative to hormone replacement therapy has emerged yet the long-term efficacy of isoflavones on bone in humans is unknown Our objective is to determine the three-year efficacy of isoflavone-rich soy extract in attenuating bone loss in postmenopausal women The central hypothesis is that soy isoflavones will attenuate bone loss in these women by maintaining bone formation which is modulated by growth factors and isoflavone metabolism The rationale for this research is that current hormone therapy is fraught with adverse side effects resulting in non-compliance This randomized double-blind placebo-controlled clinical trial will examine the effects of two doses 80 or 120 mg daily of isoflavone-rich soy extract on bone in non-osteoporotic postmenopausal women N234 The specific aims of this study are 1 to determine the bone-preserving effects of isoflavones on lumbar spine bone mineral density BMD 2 to relate treatment-induced changes in BMD to changes in biochemical markers of bone turnover 3 to identify potential mechanisms by which isoflavones prevent or modulate bone loss by measuring endogenous estrogens sex hormone-binding globulin insulin-like growth factor-I IGF-I urinary minerals serum 25OHvitamin D plasma isoflavones and their metabolites and customary intake of isoflavone-containing soy and 4 to ascertain the safety of isoflavone-rich soy extract Postmenopausal women will be recruited at two sites 117 at Iowa 117 at California Random effects repeated measures analyses will be used to characterize change in BMD as the primary outcome estimate treatment-induced effects and depict change in markers of bone turnover in relation to BMD change We will use intent-to-treat for the primary test but also account for potential modulators reproductive hormones IGF-I plasma isoflavones that affect bone as indicated in specific aim 3
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-073 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR046922 |
| R01AR046922 | NIH | None | None |