Nutrition Status, BMD, and SSRIs

NCT ID: NCT03383861

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13027 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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BMD

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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SSRI long-term user

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

Dual-Energy X-ray Absorptiometry (DXA)

Intervention Type DIAGNOSTIC_TEST

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.

Dual-Energy X-ray Absorptiometry (DXA)

Intervention Type DIAGNOSTIC_TEST

BMD t-score derived from DXA scan

Interventions

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Dual-Energy X-ray Absorptiometry (DXA)

BMD t-score derived from DXA scan

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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174318

Identifier Type: -

Identifier Source: org_study_id

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