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NCT02108509 · ClinicalTrials.gov registry record

Bone Disease in Chronic Pancreatitis: A Complex Phenomenon

A clinical trial, sponsored by University of Nebraska.

Completed
Registry status
55
Enrollment target

NCT02108509: Completed study, sponsored by University of Nebraska.

NCT02108509 is a clinical trial that has completed, run by University of Nebraska. The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02108509 has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
55 participants
Enrollment target

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.

Primary Outcome

Our hypothesis is that there is a high prevalence of low bone density in patients with chronic pancreatitis. We will measure bone density with a bone density (DXA) scan and also obtain fracture history to determine the prevalence of low bone density.

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2014-05-05
Est. Completion 2018-07-18
University of Nebraska

407 total trials

What the finished NCT02108509 record still lists

NCT02108509 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 55 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT02108509 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02108509 about?

NCT02108509 is a clinical study titled "Bone Disease in Chronic Pancreatitis: A Complex Phenomenon". 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/...

What is the current status of trial NCT02108509?

This trial is currently completed. The enrollment target is 55 participants. The study started on 2014-05-05. Estimated completion is 2018-07-18.

Who is sponsoring clinical trial NCT02108509?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02108509, the US trial registry maintained by the National Library of Medicine. NCT02108509 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.