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Bone Disease in Chronic Pancreatitis: A Complex Phenomenon

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ClinicalTrials.gov Identifier: NCT02108509
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Brian Boerner, MD, University of Nebraska

Study Description
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Brief 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.

Condition or disease
Chronic Pancreatitis Osteopenia Osteoporosis

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Study Design
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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bone Disease in Chronic Pancreatitis: A Complex Phenomenon
Study Start Date : May 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : July 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To define the prevalence of low bone density (osteopenia or osteoporosis) in patients with chronic pancreatitis [ Time Frame: Single time point (at time of data collection) ]
    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.


Secondary Outcome Measures :
  1. Prevalence of hypogonadism in patients with chronic pancreatitis. [ Time Frame: Single time point (at time of data collection) ]
    We hypothesize that the prevalence of hypogonadism will be higher than the general population in patients with chronic pancreatitis. We will utilize clinical history and measurements of sex hormones (testosterone for men, estradiol for women) to determine the prevalence of hypogonadism in this patient population.

  2. Hypogonadism and/or opioid medication use are independent risk factors for low bone density in patients with chronic pancreatitis. [ Time Frame: Single time point (at time of data collection) ]
    We hypothesize that hypogonadism and opioid medication use are independent risk factors for low bone density in patients with chronic pancreatitis. We will utilize clinical history and serum hormone levels to define subjects with hypogonadism, and obtain detailed medication lists to define opioid medication use for each subject. This information will be analyzed along with other variables to determine if hypogonadism and/or opioid use are independently associated with low bone density.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Both males and females with diagnosis of chronic pancreatitis
Criteria

Inclusion Criteria:

  • Age 19-75 years
  • Diagnosis of Chronic Pancreatitis, as defined by specific clinical criteria

Exclusion Criteria:

  • Refusal to complete the consent process in it's entirety.
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108509


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Brian Boerner, M.D. University of Nebraska
More Information
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Publications:

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Responsible Party: Brian Boerner, MD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT02108509     History of Changes
Other Study ID Numbers: 113-14-FB
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Keywords provided by Brian Boerner, MD, University of Nebraska:
Chronic Pancreatitis
Osteopenia
Osteoporosis
Hypogonadism
Opioid medications
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Pancreatitis
Pancreatitis, Chronic
 Musculoskeletal Diseases
Metabolic Diseases
Pancreatic Diseases
Digestive System Diseases