Antidepressants and Bone Mineral Density

Bone Mineral Density Quantitative Trait Locus 7 Clinical Trial

Official title:

International Committee of Medical Journal Editors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179268
• Other study ID #: [2012] NO31260237/C090103
• Status: Completed
• Phase: Phase 3
• First received: June 19, 2014
• Last updated: June 28, 2014
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Guiyang Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 48 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bone Mineral Density Quantitative Trait Locus 7

Intervention

Drug:
• sertraline
50mg, 50-150mg/d,qd for one year
• citalopram
20mg, 20-40mg/d,qd,for one year
• venlafaxine
venlafaxine,25mg, 75-100mg/d, bid, for one year
• reboxetine
reboxetine,4mg, 4-8mg/d,qd for one year

Behavioral:
• control
50min, every week for three months, every month, for nine months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guiyang Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density (BMD)		Change from Baseline in bone mineral density at one year	Yes