NCT03383861

Brief Summary

The association between selective serotonin reuptake inhibitor (SSRI) use and bone mass density (BMD) has been debated. Some have suggested features of depression, which SSRIs are prescribed to treat, may be a cause of decreased BMD, such as poor overall food intake at the time of SSRI use. Our study seeks to determine whether SSRI use in adults is associated with lower than average BMD, and if there is an association between low micronutrient intake, SSRI use, and a low BMD.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,027

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

9.9 years

First QC Date

December 19, 2017

Last Update Submit

January 8, 2024

Conditions

BMD

Outcome Measures

Primary Outcomes (1)

  • BMD t-score

    NHANES DXA measurement taken 2005-2014

Study Arms (2)

SSRI long-term user

Adults, 655 with an SSRI prescription ≥180 days and identified in the National Health and Nutrition Examination Survey (NHANES) data.

Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)

Non-user

Adults, 12,372 non-users, were identified in the National Health and Nutrition Examination Survey (NHANES) data.

Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)

Interventions

Dual-Energy X-ray Absorptiometry (DXA)DIAGNOSTIC_TEST

BMD t-score derived from DXA scan

Non-userSSRI long-term user

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

NHANES participants

You may qualify if:

  • Included adult NHANES participants are those who participated in the Dual-Energy X-ray Absorptiometry (DXA) femur-neck BMD test and responded in full to the demographic, pharmaceutical, and dietary surveys.

You may not qualify if:

  • Pregnancy, incomplete survey responses, incomplete DXA results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

January 1, 2005

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 10, 2024

Record last verified: 2024-01