NCT02179268

Antidepressants and Bone Mineral Density

International Committee of Medical Journal Editors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Guiyang Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 48 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Mineral Density Quantitative Trait Locus 7

Interventions

Type	Name	Description
DRUG	sertraline	50mg, 50-150mg/d,qd for one year
DRUG	citalopram	20mg, 20-40mg/d,qd,for one year
DRUG	venlafaxine	venlafaxine,25mg, 75-100mg/d, bid, for one year
DRUG	reboxetine	reboxetine,4mg, 4-8mg/d,qd for one year
BEHAVIORAL	control	50min, every week for three months, every month, for nine months

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-07-01
• Last updated: 2014-07-01