Bone Disease in Chronic Pancreatitis: A Complex Phenomenon

Learn more about:
Related Clinical Trial
Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis Prospective Registry Of Therapeutic EndoscopiC ulTrasound Intermittent Fasting for Pancreatitis Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies, the PROCEED Study Relationship of CP and AP Personalized Education and Pain Response in Chronic Pancreatitis A Prospective Cohort Study of Large Pancreatic Radiolucent Stone Risk Factors for Post-ESWL and Post-ERCP Pancreatitis Intraductal Liposomal Bupivacaine for Chronic Pancreatitis An Observational Study on the Natural Course of Chronic Pancreatitis Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL Malnutrition in Chronic Gastrointestinal Diseases, Cross-sectional Study Malnutrition in Chronic Pancreatitis, Trans-sectoral Study Project Survival-Prospective Biomarker Discovery Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study Volatiles in Breath and Headspace Analysis – Diagnostic Markers Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis Cancer in Patients With Gabapentin (GPRD) A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma Rectal Indomethacin to Prevent Post ESWL-pancreatitis T-EUS for Gastrointestinal Disorders: A Multicenter Registry Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool Contrast EUS of the Pancreas Idiopathic Recurrent Acute Pancreatitis (IRAP) Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions Endoscopic Ultrasound Guided Tissue Sampling (The SharkBITE Study) Trial of Index Cholecystectomy Versus Scheduled Cholecystectomy in Biliary Pancreatitis Endoscopic Ultrasound (EUS) Processor Comparison The North American Pancreatitis Study A Prospective Observational Study of TPIAT Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant Dexmedetomidine Versus Placebo in Endoscopic Retrograde Cholangiopancreatography (ERCP) Sedation Economisation of Whipple Resection Using an Ultrasonic Dissection Device Biospecimens for Identification of Diseases of the Pancreas. Diagnosis of Bile Duct Strictures Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD) Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis DNA Promoter Hypermethylation as a Blood Based Maker for Pancreatic Cancer Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT Prospective Study of Celiac Block Injection: 1 vs. 2 Online Health Assessment to Support Comprehensive Care Needle-based Confocal Endomicroscopy Examination of Pancreatic Masse Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea Extracorporeal Shock Wave Lithotripsy Versus Single Operator Pancreatoscopy and Intraductal Lithotripsy for the Treatment of Pancreatic Duct Stones Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population Role of CXCR2 Ligands/CXCR2 Biological Axis in Pancreatic Cancer Mesenchymal Stem Cell and Islet Co-transplantation Analysis of Graft Function Following Autologous Islet Transplantation Carbon Monoxide-Saturated Medium for Islet Isolation Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) in Focal Pancreatic Masses Endoscopic Ultrasound Elastography in Pancreatic Masses Digital Catheter Based Pancreatoscopy (SpyGlassDS) for the Management of Symptomatic Pancreatic Duct Stones in Selected Patients With Chronic Pancreatitis A Prospective Study of Natural History of Pancreatitis Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain ESWL Versus ESWL and Endoscopic Treatment SpHincterotomy for Acute Recurrent Pancreatitis A Prospective Study of EUS Guided Celiac Block A Dose Ranging Study Evaluating Efficacy and Safety of NI-03 Examining Macrophage Influx and Vascularization in Chronic Pancreatitis Enzyme Suppletion in Exocrine Pancreatic Dysfunction ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis Internet-based Pain Self-management for Persons With Acute Recurrent and Chronic Pancreatitis Pain Comparison of Extracorporeal Shock Wave Lithotripsy (ESWL) Alone and ESWL Plus Endoscopy for Painful Chronic Pancreatitis A Phase IIa Study With Escalating Dose of MS1819-SD Decrease of Recurrent Pancreatitis Celiac Plexus Block for Chronic Pancreatitis RCT Pancreatic Perfusion Using Secretin and MRI Viokase 16, Viokase16 Plus Nexium and Nexium Alone Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic Pancreatitis Clinical Trial to Evaluate the Endoscopic Ultrasound Guided Celiac Plexus Block for Treatment of Pain in Chronic Pancreatitis Endoscopic Stenting for Chronic Abdominal Pain WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures Safety and Efficacy of ESWL for Geriatric Patients With Chronic Pancreatitis Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) The Incretin Effect in Patients With Chronic Pancreatitis Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis Percutaneous Lesioning Splanchnic Nerves in Patients With Chronic Pancreatitis Fibro-inflammatory Progression From Acute to Chronic Pancreatitis CT Pancreas Perfusion CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis Vitamin D Substitution for Patients With Chronic Pancreatitis and Malabsorption The Natural History of Chronic Pancreatitis BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency Is There an Association Between Chronic Pancreatitis and Pulmonary Function Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer The Effect of Vitamin D Substitution on the Development of Chronic Pancreatitis Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis Endoscopic Ultrasound Compared With Pancreatic Function Testing for Diagnosis of Chronic Pancreatitis A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing Pain and Chronic Pancreatitis – Clinical End Experimental Studies A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis Trial of Indomethacin in Chronic Pancreatitis The Diagnosis of Chronic Pancreatitis Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality Effect of Acetyl-L-carnitine on Chronic Pancreatitis Establishing Standards for Normal Pancreatic EUS The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis Secretin Infusion for Pain Due to Chronic Pancreatitis Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis Elastography in the Diagnosis of Chronic Pancreatitis The PASTEC Study: Endoscopic Stenting Versus Surgery for the Treatment of Bile Duct Stricture in Chronic Pancreatitis Covered Metal Stent for Benign Biliary Stricture Caused by Chronic Pancreatitis tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies Endoscopic Versus Surgical Treatment of Chronic Pancreatitis Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis Novel Breath Test to Detect Early Stage Chronic Pancreatitis Quality of Life Assessment of Chronic Pancreatitis Endoscopic Interventions Dietary Soy Isoflavones In Chronic Pancreatitis Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis Nerve Growth Factor in Chronic Pancreatitis Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT) Role of Antioxidants Supplementation in Chronic Pancreatitis Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis Bone Disease in Chronic Pancreatitis: A Complex Phenomenon Correlation of Chronic Pancreatitis Pathology Features With Endoscopic Ultrasound (EUS) Criteria

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


Primary Outcome

To define the prevalence of low bone density (osteopenia or osteoporosis) in patients with chronic pancreatitis

Secondary Outcome

 Prevalence of hypogonadism in patients with chronic pancreatitis.

Condition

Chronic Pancreatitis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

55

Start Date

May 2014

Completion Date

July 2018

Primary Completion Date

December 2017

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
      

Gender

All

Ages

19 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Brian Boerner, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02108509

Organization ID

113-14-FB


Responsible Party

Principal Investigator

Study Sponsor

University of Nebraska


Study Sponsor

Brian Boerner, M.D., Principal Investigator, University of Nebraska


Verification Date

March 2019