Antidepressants and Bone Mineral Density

Guiyang Medical University

Status and phase: Completed; Phase 3

Conditions: Bone Mineral Density Quantitative Trait Locus 7

Treatments: Drug: sertraline; Drug: reboxetine; Behavioral: control; Drug: citalopram; Drug: venlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT02179268

[2012] NO31260237/C090103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 20 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 4 patient groups

sertraline & control

Active Comparator group

Description:

sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

Treatment:

Drug: venlafaxine

Behavioral: control

Drug: citalopram

Drug: reboxetine

Drug: sertraline

citalopram & Control

Active Comparator group

Description:

citalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

Treatment:

Drug: venlafaxine

Behavioral: control

Drug: citalopram

Drug: reboxetine

Drug: sertraline

venlafaxine & control

Active Comparator group

Description:

venlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

Treatment:

Drug: venlafaxine

Behavioral: control

Drug: citalopram

Drug: reboxetine

Drug: sertraline

reboxetine & control

Active Comparator group

Description:

reboxetine 4-8mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).

Treatment:

Drug: venlafaxine

Behavioral: control

Drug: citalopram

Drug: reboxetine

Drug: sertraline