Bone Diseases, MetabolicNCT00001916
Use of Bone Biopsy to Better Understand the Causes of Decreased Bone Mineral Density in Depression
An observational study of Bone Diseases, Metabolic and Depression, Involutional, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Diseases, Metabolic, Depression, Involutional, Osteoporosis
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Aug 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Keywords
- Bone Remodeling, Corticosteroids, Cytokine, Depression, Glucocorticoids, Osteopenia, Osteoporosis, Primary Affective Disorder
- Medical subject headings
- Bone Diseases, Metabolic, Depressive Disorder, Major, Osteoporosis, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1999
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bone Diseases, MetabolicStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 17 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001916
- Sponsor's protocol ID
- 990049
- Other IDs
- 99-M-0049
- Status last verified
- Feb 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 8815939Delmas 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.
PubMed 8943167Berenson 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.
PubMed 8559201
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00001916
- Acronym / sponsor ID
- 990049
- Keywords
- Bone Remodeling, Corticosteroids, Cytokine, Depression, Glucocorticoids, Osteopenia, Osteoporosis, Primary Affective Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Mar 1999
- Study completion
- Aug 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8815939Michelson 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.
- Background: PubMed 8943167Delmas 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.
- Background: PubMed 8559201Berenson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Diseases, Metabolic and Depression, Involutional, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001916, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.