Skip to content

Antidepressants and Bone Mineral Density

International Committee of Medical Journal Editors

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02179268
Enrollment
203
Registered
2014-07-01
Start date
2012-03-31
Completion date
2014-04-30
Last updated
2014-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Mineral Density Quantitative Trait Locus 7

Keywords

Antidepressants, bone mineral density, bone turnover markers

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.

Interventions

DRUGsertraline

50mg, 50-150mg/d,qd for one year

DRUGcitalopram

20mg, 20-40mg/d,qd,for one year

DRUGvenlafaxine

venlafaxine,25mg, 75-100mg/d, bid, for one year

reboxetine,4mg, 4-8mg/d,qd for one year

BEHAVIORALcontrol

50min, every week for three months, every month, for nine months

Sponsors

Guiyang Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 48 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
bone mineral density (BMD)Change from Baseline in bone mineral density at one year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026