Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001916
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Use of Bone Biopsy to Better Understand the Causes of Decreased Bone Mineral Density in Depression
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Bone Biopsy for Histomorphometry and Analysis of Bone Marrow Derived Osteoblast and Osteoclast Progenitors to Explore Mechanisms of Decreased Bone Mineral Density in Depression
Status:
COMPLETED
Status Verified Date:
1999-02
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:
None
Brief Summary:
In this study researchers would like to learn more about the low levels of bone mineral density seen in approximately half of women in their forties diagnosed as currently having or previously had depression
Bones are always undergoing a process of building formation and breakdown resorption This process is referred to as bone remodeling When more bone is formed than resorbed the density level of calcium in bone increases and the bones become stronger However if more bone is resorbed than formed the density of bone decreases and the bones become weak This condition is called osteoporosis
It is unknown if women with depression have decreased bone mineral density as a result of too much breakdown of bone or not enough building It is important to know the cause of low bone mineral density because it will influence the way a patient is treated Medications like bisphosphonates are used when there is too much bone breakdown Growth hormone replacement can be given in cases where there is not enough bone production Presently bone biopsy and a procedure known as histomorphometry can determine what processes are going on in bones
Researchers have decided to use a sample of bone biopsy from part of the hip bone iliac crest In addition researchers will collect a sample of bone marrow the soft tissue found in the center of bones to tell them more about the biochemical cellular and molecular processes that may be contributing to the problem of decreased bone density in depressed premenopausal women
Bones are always undergoing a process of building formation and breakdown resorption This process is referred to as bone remodeling When more bone is formed than resorbed the density level of calcium in bone increases and the bones become stronger However if more bone is resorbed than formed the density of bone decreases and the bones become weak This condition is called osteoporosis
It is unknown if women with depression have decreased bone mineral density as a result of too much breakdown of bone or not enough building It is important to know the cause of low bone mineral density because it will influence the way a patient is treated Medications like bisphosphonates are used when there is too much bone breakdown Growth hormone replacement can be given in cases where there is not enough bone production Presently bone biopsy and a procedure known as histomorphometry can determine what processes are going on in bones
Researchers have decided to use a sample of bone biopsy from part of the hip bone iliac crest In addition researchers will collect a sample of bone marrow the soft tissue found in the center of bones to tell them more about the biochemical cellular and molecular processes that may be contributing to the problem of decreased bone density in depressed premenopausal women
Detailed Description:
We have recently found that premenopausal women with past or current depression show clinically significant decrements in bone mineral density in the hip and spine rendering more than 40 at present risk for osteoporotic fracture Recent pharmacologic advances provide the opportunity to ameliorate or reverse this clinically significant loss of bone mineral density Available agents such as bisphosphonates or growth hormone are each preferentially effective in the contexts of increased and decreased bone turnover respectively It is currently not known whether the decrease in bone mineral density in depression is associated with increased or decreased bone turnover because the many endocrine changes associated with depression of possible relevance to decreased bone mineral density have disparate effects on bone turnover dynamics At present the only definitive way to determine the status of bone turnover in humans is via bone biopsy and histomorphometric evaluation In addition bone marrow routinely obtained during standard bone biopsy would provide the opportunity to culture osteoblast and osteoclast progenitor cells to determine possible abnormalities in differentiation and function as a means of exploring the cellular and molecular mechanisms of decreased bone mineral density in depression In light of the high incidence of depression in women decreased bone mineral density in patients with past or current depression has considerable public health implications
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 |
|---|---|---|---|
| 99-M-0049 | None | None | None |