MedTrace Logo

Bone Disease in Chronic Pancreatitis: A Complex Phenomenon

NCT02108509 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2023-09-25

No results posted yet for this study

Summary

The purpose of this study is to define the prevalence of low bone density (osteopenia/osteoporosis) in patients with chronic pancreatitis. Secondary aims include investigating the prevalence of hypogonadism (low sex hormones) in patients with chronic pancreatitis and determining if hypogonadism and/or use of narcotic pain medications are risk factors for low bone density in this patient population.

1. Hypothesis:

Patients with chronic pancreatitis are at increased risk of low bone density (osteopenia/osteoporosis), and hypogonadism (low sex hormone levels) and narcotic pain medication use are independent risk factors for the development of low bone density in this patient population.
2. The outcome measures include:

i) Prevalence of low bone density (osteopenia/osteoporosis) in patients with chronic pancreatitis (as determined by DXA scan and fracture history).

ii) Prevalence of hypogonadism (low sex hormones) in patients with chronic pancreatitis (as determined by sex hormone levels and clinical history).

iii) Identification of hypogonadism and/or opioid use as risk factors for low bone density in patients with chronic pancreatitis (as determined by univariate and multivariate analysis of multiple risk factors).
3. After obtaining written consent from potential subjects, a questionnaire will be performed outlining risk factors for low bone density. Dual X-ray absorptiometry (DXA scan) will be performed to evaluate for low bone density and a blood test will be performed to evaluate for low sex hormones, low levels of vitamin D, and other risk factors for low bone density.

Conditions

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Brian Boerner, MD · University of Nebraska

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-05
Primary Completion
2017-12-01
Completion
2018-07-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02108509 on ClinicalTrials.gov