Nutrition Status, BMD, and SSRIs

Nutrition Status, Bone Mass Density, and Selective Serotonin Reuptake Inhibitors

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.

Study Overview

• Status: Terminated
• Conditions: BMD
• Intervention / Treatment: Diagnostic test: Dual-Energy X-ray Absorptiometry (DXA)

• Study Type: Observational
• Enrollment (Actual): 13027

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

NHANES participants

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pregnancy, incomplete survey responses, incomplete DXA results

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); BMD t-score derived from DXA scan
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); BMD t-score derived from DXA scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BMD t-score	NHANES DXA measurement taken 2005-2014

Collaborators and Investigators

• Sponsor: University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 174318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No