Nutrition Status, BMD, and SSRIs | NCT03383861

Studies
Nutrition Status, BMD, and SSRIs

NCT03383861

Sponsor

University of New Mexico

Status

Terminated

Last Update Posted

Jan 10, 2024Actual

Enrollment

13,027Actual

Phase

Not provided

Conditions

Interventions

Dual-Energy X-ray Absorptiometry (DXA)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This is not a clinical trial and is only a retrospective chart review. This was inadvertently entered into the system as a clinical trial.

Expanded Access Info

Start Date

Jan 2005Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 19, 2017

First Submission Date that Met QC Criteria

Dec 19, 2017

First Posted Date

Dec 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2024

Last Update Posted Date

Jan 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13,027Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dual-Energy X-ray Absorptiometry (DXA)	Diagnostic Test	BMD t-score derived from DXA scan	Non-user SSRI long-term user

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

NHANES participants

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015502	Absorptiometry, Photon

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided