Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010686
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2001-02-02
Brief Title:
Dietary Phytoestrogens and Bone Metabolism
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Dietary Phytoestrogens and Bone Metabolism
Status:
COMPLETED
Status Verified Date:
2006-08
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:
None
Brief Summary:
The purpose of this study is to determine whether dietary phytoestrogens are an effective alternative to postmenopausal exogenous estrogen replacement therapy in preventing bone loss
Detailed Description:
Osteoporosis in postmenopausal women is one of the most important public health challenges of our time With millions of women affected and billions of dollars being spent for its complications we need to develop effective approaches to this disease Postmenopausal women are at particular risk because the loss of estrogen associated with the menopause leads to bone loss of much greater magnitude than one would expect on the basis of age alone Estrogen replacement therapy a logical and effective therapeutic approach has been associated with serious concerns about adverse events and thus limited use The recent development of selective estrogen receptor modulators SERMS may help if they continue to show promise Interest in natural sources of estrogenic substances to prevent postmenopausal bone loss is an expected outgrowth of the general interest in alternative medicinals for a wide variety of human disorders Concerns about the potential for adverse consequences of the conventional use of estrogen replacement therapy and limited knowledge about long term use of SERMS- add support to this quest No systematic investigation of the role of dietary phytoestrogens on bone mass and skeletal dynamics has yet been conducted With the dramatic increase in interest in these sources of estrogenic activity it is important for us to determine whether these agents are efficacious Otherwise this field will be plagued for years to come by incomplete anecdotal and scientifically poorly documented actions of these agents on bone metabolism It is our expectation that this study will begin to provide the documentary information that the field so clearly needs The rationale for exploring the potential for phytoestrogens in the maintenance of skeletal health in postmenopausal women is clear and compelling
Women will be randomly assigned to one of three healthy eating plans and over the course of the year-long study will learn to choose and cook foods to help optimize health as they go through menopause and beyond
Women will be randomly assigned to one of three healthy eating plans and over the course of the year-long study will learn to choose and cook foods to help optimize health as they go through menopause and beyond
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 |
|---|---|---|---|
| P50AT000090-01 | NIH | None | httpsreporternihgovquickSearchP50AT000090-01 |