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Nutrition Status, BMD, and SSRIs

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ClinicalTrials.gov Identifier: NCT03383861
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Shannon Kindilien, University of New Mexico

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.

Condition or disease Intervention/treatment
BMD Diagnostic Test: Dual-Energy X-ray Absorptiometry (DXA)

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Study Type : Observational
Actual Enrollment : 13027 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Nutrition Status, Bone Mass Density, and Selective Serotonin Reuptake Inhibitors
Actual Study Start Date : January 2005
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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




Primary Outcome Measures :
  1. BMD t-score [ Time Frame: NHANES DXA measurement taken 2005-2014 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
NHANES participants
Criteria

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

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Responsible Party: Shannon Kindilien, Graduate Student, University of New Mexico
ClinicalTrials.gov Identifier: NCT03383861     History of Changes
Other Study ID Numbers: 174318
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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