Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bone Disease in Chronic Pancreatitis: A Complex Phenomenon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 5, 2014
First Posted Date April 9, 2014
Last Update Posted Date March 4, 2019
Study Start Date May 2014
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02108509 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 9, 2014)
  • 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.
Original Secondary Outcome Measures
 (submitted: April 5, 2014)
  • Determine the 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.
  • Determine if 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone Disease in Chronic Pancreatitis: A Complex Phenomenon
Official Title Bone Disease in Chronic Pancreatitis: A Complex Phenomenon
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.
Detailed Description

Chronic pancreatitis is defined as a continuing inflammatory disease of the pancreas characterized by irreversible morphologic changes that typically cause pain and/or permanent loss of function. The annual incidence of chronic pancreatitis in the Unites States is 5-12 per 100,000 and prevalence of 50 per 100,000 persons though the incidence is rising over time . The most common symptoms related to chronic pancreatitis include steatorrhea and abdominal pain. Pain with chronic pancreatitis can be severe and debilitating and opioid pain medications are frequently utilized in the management of these symptoms .

A number of chronic malabsorptive disorders, including Crohn's disease, celiac disease, and cystic fibrosis are known to be associated with decreased bone mineral density. Similarly, there is increasing data supporting low bone mineral density (osteopenia and osteoporosis) in patients with chronic pancreatitis, though the exact mechanisms remain unclear.

A meta-analysis of 11 observational studies of chronic pancreatitis reported the prevalence of osteopenia to be 39.8% and osteoporosis 23.4%, with the cumulative prevalence of low bone density (osteopenia and osteoporosis) being almost 65%. Interestingly, out of the eleven studies in this meta-analysis, eight were performed in Europe, two in India, and one in South America.

Some studies in chronic pancreatitis have described a link between Vitamin D deficiency and risk for low bone density. Other proposed risk factors for low bone density in this patient population include age, gender, malnutrition, alcohol use, smoking, and variation and duration of pancreatitis. However, other potential novel risk factors for low bone density exist in patients with chronic pancreatitis. These factors include chronic use of opioid medications and hypogonadism.

Opioid use is prominent in patients with chronic pancreatitis. At least 85% of patients suffering from chronic pancreatitis will develop pain and despite many different treatment methods, many patients with chronic pancreatitis do not get respite from their pain, even after several years. Therefore, up to 50% or more of all patients with chronic pancreatitis will utilize opioid medications as part of their pain management strategy. Opioid medication use has been shown to be a risk factor for low bone density. The exact mechanism behind opioid-induced low bone density is not known but is likely multi-factorial.

To date, the prevalence of hypogonadism in patients with chronic pancreatitis is unknown but would be expected to be higher than the general population due to the risk factors of opioid use, chronic illness, and potentially malnutrition. This warrants further investigation as a higher prevalence of hypogonadism could directly impact bone health in this cohort, not to mention potential effects of hypogonadism on quality of life and fertility.

This research project will utilize Dual X-ray absorptiometry (DXA scan) and clinical history to determine the prevalence of low bone density (osteopenia/osteoporosis) in our cohort; blood draw, clinical history, and questionnaire to determine prevalence of hypogonadism in our cohort; and blood draw, clinical history, and questionnaire to examine specific risk factors for low bone density in our cohort.

After obtaining written consent from potential subjects, a questionnaire will be performed outlining smoking history, alcohol use history, fracture history, signs/symptoms of hypogonadism, exercise patterns, and opioid medication use history. A one-time Dual X-ray absorptiometry (DXA scan) will be performed on each subject. A one-time blood draw will be performed on each subject, with the following lab tests being performed on each subject:

  • 25-hydroxy Vitamin D
  • Comprehensive Metabolic Panel
  • Total Testosterone (males)
  • Estradiol (females)
  • Lutenizing hormone (LH)
  • Follicle-stimulating hormone (FSH)
  • Steroid hormone binding globulin (SHBG)
  • Prolactin
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Both males and females with diagnosis of chronic pancreatitis
Condition
  • Chronic Pancreatitis
  • Osteopenia
  • Osteoporosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 1, 2019)
55
Original Estimated Enrollment
 (submitted: April 5, 2014)
70
Actual Study Completion Date July 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02108509
Other Study ID Numbers 113-14-FB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Brian Boerner, MD, University of Nebraska
Study Sponsor University of Nebraska
Collaborators Not Provided
Investigators
Principal Investigator: Brian Boerner, M.D. University of Nebraska
PRS Account University of Nebraska
Verification Date March 2019