Bone Disease in Chronic Pancreatitis: A Complex Phenomenon

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Brian Boerner, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT02108509
First received: April 5, 2014
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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
Chronic Pancreatitis
Osteopenia
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bone Disease in Chronic Pancreatitis: A Complex Phenomenon

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Prevalence of hypogonadism in patients with chronic pancreatitis. [ Time Frame: Single time point (at time of data collection) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02108509

Contacts
Contact: Brian Boerner, M.D. 402-559-6208 bboerner@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Brian Boerner, MD    402-559-6208    bboerner@unmc.edu   
Sub-Investigator: Namita Gupta, MBBS         
Sub-Investigator: Shailender Singh, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Brian Boerner, M.D. University of Nebraska
  More Information

Publications:

Responsible Party: Brian Boerner, MD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT02108509     History of Changes
Other Study ID Numbers: 113-14-FB
Study First Received: April 5, 2014
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Chronic Pancreatitis
Osteopenia
Osteoporosis
Hypogonadism
Opioid medications

Additional relevant MeSH terms:
Osteoporosis
Pancreatitis
Pancreatitis, Chronic
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014