CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02108509
NCT02108509N/ACompleted

Bone Disease in Chronic Pancreatitis: A Complex Phenomenon

University of Nebraska·observational·Posted Apr 9, 2014·Updated Sep 25, 2023

In Brief

An observational study for Chronic Pancreatitis and 2 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 9, 2014
Enrollment StartMay 5, 2014
Primary CompletionDec 1, 2017
Study CompletionJul 18, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.2 years ago