Skeletal Effects of Chronic Night Shift

Recruiting

• Conditions: Osteoporosis; Circadian Rhythm Sleep Disorder, Shift Work Type

• Registration Number: NCT05091021
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The specific aim of this observational study is to characterize changes in bone turnover makers (BTMs), bone mineral density (BMD), and bone microarchitecture in a cohort of nurses during their first year of night compared to day shift work. The hypothesis is that night shift nurses will have poorer bone health indices at one year compared to day shift nurses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-25
• Study Start: 2021-10-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in change of propeptide of type 1 procollagen (P1NP) over 1 year	From baseline up to 12 months	Difference in change of P1NP over 1 year between the two groups (night vs. day shift nurses), as measured via bone biomarker assays (immunodiagnostic systems, chemiluminescence, immunoassay)

Secondary Outcome Measures

Name	Time	Method
Between-group differences in the change in osteocalcin	From baseline up to 12 months	Between-group differences in the change in another bone formation marker (osteocalcin)
Between-group differences in the change in CTX (C-telopeptide of type I collagen)	From baseline up to 12 months	Between-group differences in the change in a bone resorption marker (CTX)
DXA-derived areal bone mineral density (aBMD) changes	From baseline up to 12 months	Between-group differences in aBMD at the lumber spine, total hip and femoral neck measured by DXA
Change in bone microarchitecture	From baseline up to 12 months	Change in trabecular volumetric BMD (vBMD) derived from high-resolution peripheral quantitative computed tomography (HR-pQCT)

Trial Locations

Locations (1)

CU Anschutz; 🇺🇸 Aurora, Colorado, United States