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Antidepressants and Bone Mineral Density

Information source: Guiyang Medical College
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bone Mineral Density Quantitative Trait Locus 7

Intervention: sertraline (Drug); citalopram (Drug); venlafaxine (Drug); reboxetine (Drug); control (Behavioral)

Phase: Phase 3

Status: Completed

Sponsored by: Guiyang Medical College

Official(s) and/or principal investigator(s):
yiming wang, Ph.D, Study Chair, Affiliation: World Health Organization

Summary

The aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and secondary endpoints being bone turnover markers.

Clinical Details

Official title: International Committee of Medical Journal Editors

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: bone mineral density (BMD)

Detailed description: These results have overt clinical implications. They suggest a noxious effect, particularly of selective serotonin reuptake inhibitor (SSRI) antidepressants, on bone. Osteoporosis and fracture is overtly the problem of the elderly. However, the process of skeletal consolidation begins in childhood and the corresponding phase of demineralisation proceeds at a glacial pace and lasts throughout adulthood, as a consequence antidepressant therapy is likely to have a substantive impact on a phenomenon likely to manifest decades hence. It is known that numerically small changes in bone mineral density are associated with a substantial increase in fracture risk. Because the SSRIs have only been in widespread use for two decades, it is plausible that the consequences of this adverse effect are yet to emerge. These data consequently suggest a recalibration of the risk/benefit ratio of this class of agents and additionally beg the question of the potential role of screening for bone mineral density in this at-risk population group.

Eligibility

Minimum age: 20 Years. Maximum age: 48 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participants needed to have a primary diagnosis of depression with Zung Self Rated

Depression Scale (SDS) > 53, and Hamilton Depression Scale (HAMD) ≥20. Exclusion Criteria:

- The patients with hyperparathyroidism, myeloma or other disorders known to affect

bone metabolism

- Use of estrogen

- Calcitonin drugs

- Previous antidepressant or other psychiatric drug use or prior treatment history

Locations and Contacts

Additional Information

Starting date: March 2012
Last updated: June 28, 2014

Page last updated: August 23, 2015

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