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
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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.
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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.
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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).
- 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 |
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Chronic Pancreatitis Osteopenia Osteoporosis |

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 |

- 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.
- 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.
- 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.

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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 |
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

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
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: | Brian Boerner, M.D. | University of Nebraska |
Responsible Party: | Brian Boerner, MD, Assistant Professor, University of Nebraska |
ClinicalTrials.gov Identifier: | NCT02108509 |
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 |
Chronic Pancreatitis Osteopenia Osteoporosis Hypogonadism Opioid medications |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Pancreatitis Pancreatitis, Chronic |
Musculoskeletal Diseases Metabolic Diseases Pancreatic Diseases Digestive System Diseases |