Terminé

Bone Biopsy for Histomorphometry and Analysis of Bone Marrow Derived Osteoblast and Osteoclast Progenitors to Explore Mechanisms of Decreased Bone Mineral Density in Depression

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Ce qui est collecté

Collecte de données

Qui peut participer

Troubles Mentaux+7

+ Maladies osseuses

+ Trouble Dépressif

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Comment se déroule l'étude

Observationnel
Date de début : mars 1999
Voir le détail du protocole

Résumé

Sponsor principalNational Institute of Mental Health (NIMH)
Dernière mise à jour : 4 mars 2008
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 mars 1999

Date à laquelle le premier participant a commencé l'étude.

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.

NCT00001916
Sponsor principalNational Institute of Mental Health (NIMH)
Dernière mise à jour : 4 mars 2008
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

17 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles MentauxMaladies osseusesTrouble DépressifMaladies métaboliquesMaladies musculo-squelettiquesMaladies nutritionnelles et métaboliquesTroubles de l'humeurMaladies osseuses métaboliquesTrouble dépressif majeurOstéoporose

Critères

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.

Centres d'étude

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Cette étude comporte 1 site

National Institute of Mental Health (NIMH)

Bethesda, United StatesOuvrir National Institute of Mental Health (NIMH) dans Google Maps
Terminé1 Centres d'Étude