Skeletal Effects of Chronic Night Shift

NCT05091021 | Active Not Recruiting

• 2 other identifiers: 20-3014R01HL151332
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Circadian Rhythm Sleep Disorder, Shift Work Type

Outcome Measures

Primary Outcomes (1)

• Difference in change of propeptide of type 1 procollagen (P1NP) over 1 year

  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)

  From baseline up to 12 months

Secondary Outcomes (4)

• Between-group differences in the change in osteocalcin

  From baseline up to 12 months

• DXA-derived areal bone mineral density (aBMD) changes

  From baseline up to 12 months

• Change in bone microarchitecture

  From baseline up to 12 months

• Between-group differences in the change in CTX (C-telopeptide of type I collagen)

  From baseline up to 12 months

Study Arms (2)

University of Colorado Health New Nurses (Day Shift Workers)

Day shift work group nurses have greater than 50% of their shifts as day shifts.

University of Colorado Health New Nurses (Night Shift Workers)

Night shift work group nurses have greater than 50% of their shifts as night shifts.

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit volunteers from the pool of recently graduated new nurse hires at UCH. We will target our recruitment towards units that work the night shift (floor/ICU units) or day shifts (peri-operative and operating room units).

You may qualify if:

• Healthy, nonpregnant adults 20-50 years old who recently (≤6 months) graduated from nursing school and were hired by University of Colorado Hospital for their first nursing position
• For women to be eligible, they must be premenopausal, not breastfeeding, not pregnant with no plans to become pregnant during the year of observation and willing/able to maintain their current method of contraception use as detailed below.
• Willing and able to travel to/from CU-AMC for study measurements at baseline and quarterly for one full year

You may not qualify if:

• Current smokers at baseline (or within the previous year of study).
• Individuals who are concurrently participating in another research protocol that would influence their safe participation in this study. For example, participants involved in a study that requires blood draws or ingestion of experimental medication as this would increase the risk of participation in our study and/or compromise study results.
• Self-reported or newly diagnosed medical condition that is still being investigated or is not under good control, including those identified on screening labs such as:
• o Out-of-range values measured on a blood sample such as glucose, TSH, creatinine or hemoglobin, that represent clinically significant abnormalities that may jeopardize safe participation or accuracy of outcome measures, at PI discretion
• Evaluation of Psychiatric/Psychological Suitability:
• Inability to demonstrate a full understanding of the requirements and demands of the study.
• Individuals who are unaware of specific psychiatric diagnoses who have a history of having been treated with antidepressants, neuroleptic medications or major tranquilizers will be excluded from study.
• Individuals with any clinically significant sleep disorder; Diagnosis or symptoms of sleep disorders (history of significant parasomnia as an adult \[night terrors, frequent sleep walking\], insomnia, including but not limited to hypersomnias such as apnea, periodic limb movements, narcolepsy). Sleep disorders will be screened by self-report and physician interview including use of validated sleep questionnaires (PSQI, Epworth sleepiness scale, and Berlin sleep questionnaire for sleep apnea).
• Individuals on medications known to affect bone turnover (e.g., glucocorticoids, osteoporosis medications);
• Individuals with eGFR \< 60 mL/min/1.73m2 as this is known to affect CTX measurements.
• Symptoms of active illness (e.g., fever) at time of enrollment; note - participant may be studied at a later date if they have not yet started their clinical duties by that time

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

CU Anschutz

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum, plasma

MeSH Terms

Conditions

Osteoporosis; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Christine M Swanson, MD, MCR

  CU Anschutz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 25, 2021
• Study Start: October 27, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)