Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02179268
Status:
COMPLETED
Last Update Posted:
2014-07-01
First Post:
2014-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antidepressants and Bone Mineral Density
Sponsor:
Guiyang Medical University
Organization:
Study Overview
Official Title:
International Committee of Medical Journal Editors
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: