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

NCT00001916 | Completed

• 2 other identifiers: 99004999-M-0049
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Diseases, Metabolic; Depression, Involutional; Osteoporosis

Keywords

Bone Remodeling; Corticosteroids; Cytokine; Depression; Glucocorticoids; Osteopenia; Osteoporosis; Primary Affective Disorder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Michelson D, Stratakis C, Hill L, Reynolds J, Galliven E, Chrousos G, Gold P. Bone mineral density in women with depression. N Engl J Med. 1996 Oct 17;335(16):1176-81. doi: 10.1056/NEJM199610173351602.

  PMID: 8815939 BACKGROUND

• Delmas PD. Bisphosphonates in the treatment of bone diseases. N Engl J Med. 1996 Dec 12;335(24):1836-7. doi: 10.1056/NEJM199612123352409. No abstract available.

  PMID: 8943167 BACKGROUND

• Berenson JR, Lichtenstein A, Porter L, Dimopoulos MA, Bordoni R, George S, Lipton A, Keller A, Ballester O, Kovacs MJ, Blacklock HA, Bell R, Simeone J, Reitsma DJ, Heffernan M, Seaman J, Knight RD. Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group. N Engl J Med. 1996 Feb 22;334(8):488-93. doi: 10.1056/NEJM199602223340802.

  PMID: 8559201 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Depressive Disorder, Major; Osteoporosis; Depression

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: March 1, 1999
• Study Completion: August 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-02

Locations

US (1)