Osteoporosis Clinical Trial
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
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.
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. ;
N/A
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06287502 -
Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis
|
N/A | |
Completed |
NCT03822078 -
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
|
Phase 1 | |
Recruiting |
NCT05845021 -
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
|
N/A | |
Completed |
NCT00092066 -
A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
|
Phase 3 | |
Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
Completed |
NCT04736693 -
Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
|
||
Not yet recruiting |
NCT06431867 -
Primary Care Management of Osteoporosis in Older Women
|
||
Completed |
NCT02922478 -
Role of Comorbidities in Chronic Heart Failure Study
|
||
Recruiting |
NCT02635022 -
Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
|
||
Recruiting |
NCT02616627 -
Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
|
||
Active, not recruiting |
NCT02617303 -
Prevention of Falls and Its Consequences in Elderly People
|
N/A | |
Completed |
NCT02566655 -
Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis
|
Phase 1 | |
Not yet recruiting |
NCT02223572 -
Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture
|
N/A | |
Completed |
NCT03420716 -
Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women
|
N/A | |
Completed |
NCT02559648 -
Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis
|
Phase 2 | |
Unknown status |
NCT01913834 -
Nasally and sc Administered Teriparatide in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT02003716 -
DeFRA Questionnaire as an Anamnestic Form
|
N/A | |
Not yet recruiting |
NCT01854086 -
Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday
|
N/A | |
Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
Completed |
NCT01401556 -
C-STOP Fracture Trial
|
N/A |