Use of Bone Biopsy to Better Understand the Causes of Decreased Bone Mineral Density in Depression

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001916
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: February 1999
  Purpose

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.


Condition
Bone Diseases, Metabolic
Depression, Involutional
Osteoporosis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 17
Study Start Date: March 1999
Estimated Study Completion Date: August 2000
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Female patients with primary affective disorder (major depression n=17).

Controls must not have psychiatric disorders.

Subjects with past or current depression will be studied if bone mineral density in any site in either hip or spine was assessed by DEXA scan to be equal to or greater than 1 1/2 standard deviation below peak bone density.

Subjects with psychiatric illness can either be drug free or receiving any FDA approved medication for the treatment of depression, with the exception of valproic acid and carbamazepine, which are known to interfere with intestinal calcium absorption (and hence, can influence bone mineral density), and monoamine oxidase inhibitors, which can interact adversely with fentanyl in the event that it would be given for relief of pain.

During the course of the entire study all subjects must abstain from tobacco and alcohol and will be instructed to inform the physicians conducting the research about their use of prescription or non-prescription medication, including birth control pills.

Must not have any serious medical illnesses.

Must not have current or past, prolonged steroid use.

Must not be pregnant.

Must not be on anticoagulant medication.

Must not be allergic to or have shown adverse reactions to tetracyline, benzodiazepines, fentanyl, or lidocaine.

Must not have used aspirin or other non-steroidal anti-inflammatory agents in the past week.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001916

Locations
United States, Maryland
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001916     History of Changes
Other Study ID Numbers: 990049, 99-M-0049
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Bone Remodeling
Corticosteroids
Cytokine
Depression
Glucocorticoids
Osteopenia
Osteoporosis
Primary Affective Disorder

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Osteoporosis
Depression
Depressive Disorder
Depressive Disorder, Major
Metabolic Diseases
Behavioral Symptoms
Mental Disorders
Mood Disorders
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 29, 2014