Chronic PancreatitisNCT02108509
Bone Disease in Chronic Pancreatitis: A Complex Phenomenon
An observational study of Chronic Pancreatitis and Osteopenia, run by University of Nebraska at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Chronic Pancreatitis, Osteopenia, Osteoporosis
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2014to 18 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both males and females with diagnosis of chronic pancreatitis
Who may be able to join
- Age 19-75 years
- Diagnosis of Chronic Pancreatitis, as defined by specific clinical criteria
Who cannot join
- Refusal to complete the consent process in it's entirety.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
- 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.
- The outcome measures include:
- 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.
Read the 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
- Conditions
- Chronic Pancreatitis, Osteopenia, Osteoporosis
- Keywords
- Chronic Pancreatitis, Osteopenia, Osteoporosis, Hypogonadism, Opioid medications
- Medical subject headings
- Pancreatitis, Chronic, Bone Diseases, Metabolic, Osteoporosis, Hypogonadism
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the prevalence of low bone density (osteopenia or osteoporosis) in patients with chronic pancreatitis
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.
Measured: Single time point (at time of data collection)
Secondary outcomes (2)
Prevalence of hypogonadism in patients with chronic pancreatitis.
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.
Measured: Single time point (at time of data collection)
Hypogonadism and/or opioid medication use are independent risk factors for low bone density in patients with chronic pancreatitis.
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.
Measured: Single time point (at time of data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study start5 May 2014
- Primary completion1 Dec 2017
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Boerner, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108509
- Sponsor's protocol ID
- 0113-14-FB
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2014
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yadav D, Whitcomb DC. The role of alcohol and smoking in pancreatitis. Nat Rev Gastroenterol Hepatol. 2010 Mar;7(3):131-45. doi: 10.1038/nrgastro.2010.6. Epub 2010 Feb 2.
PubMed 20125091Yadav D, Timmons L, Benson JT, Dierkhising RA, Chari ST. Incidence, prevalence, and survival of chronic pancreatitis: a population-based study. Am J Gastroenterol. 2011 Dec;106(12):2192-9. doi: 10.1038/ajg.2011.328. Epub 2011 Sep 27.
PubMed 21946280Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
PubMed 23622135Nusrat S, Yadav D, Bielefeldt K. Pain and opioid use in chronic pancreatitis. Pancreas. 2012 Mar;41(2):264-70. doi: 10.1097/MPA.0b013e318224056f.
PubMed 21792080Klapdor S, Richter E, Klapdor R. Vitamin D status and per-oral vitamin D supplementation in patients suffering from chronic pancreatitis and pancreatic cancer disease. Anticancer Res. 2012 May;32(5):1991-8.
PubMed 22593477Targownik LE, Bernstein CN, Leslie WD. Risk factors and management of osteoporosis in inflammatory bowel disease. Curr Opin Gastroenterol. 2014 Mar;30(2):168-74. doi: 10.1097/MOG.0000000000000037.
PubMed 24419292Krupa-Kozak U. Pathologic bone alterations in celiac disease: etiology, epidemiology, and treatment. Nutrition. 2014 Jan;30(1):16-24. doi: 10.1016/j.nut.2013.05.027.
PubMed 24290593Haworth CS. Impact of cystic fibrosis on bone health. Curr Opin Pulm Med. 2010 Nov;16(6):616-22. doi: 10.1097/MCP.0b013e32833e2e94.
PubMed 20739891Haaber AB, Rosenfalck AM, Hansen B, Hilsted J, Larsen S. Bone mineral metabolism, bone mineral density, and body composition in patients with chronic pancreatitis and pancreatic exocrine insufficiency. Int J Pancreatol. 2000 Feb;27(1):21-7. doi: 10.1385/IJGC:27:1:21.
PubMed 10811020Dujsikova H, Dite P, Tomandl J, Sevcikova A, Precechtelova M. Occurrence of metabolic osteopathy in patients with chronic pancreatitis. Pancreatology. 2008;8(6):583-6. doi: 10.1159/000159845. Epub 2008 Sep 29.
PubMed 18824882Sudeep K, Chacko A, Thomas N, Selvakumar R, George B, Paul TV, Seshadri MS. Predictors of osteodystrophy in patients with chronic nonalcoholic pancreatitis with or without diabetes. Endocr Pract. 2011 Nov-Dec;17(6):897-905. doi: 10.4158/EP10410.OR.
PubMed 21742614Joshi A, Reddy SV, Bhatia V, Choudhuri G, Singh RK, Singh N, Bhatia E. High prevalence of low bone mineral density in patients with tropical calcific pancreatitis. Pancreas. 2011 Jul;40(5):762-7. doi: 10.1097/MPA.0b013e31821396b2.
PubMed 21441842Duggan SN, Smyth ND, Murphy A, Macnaughton D, O'Keefe SJ, Conlon KC. High prevalence of osteoporosis in patients with chronic pancreatitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2014 Feb;12(2):219-28. doi: 10.1016/j.cgh.2013.06.016. Epub 2013 Jul 12.
PubMed 23856359Sikkens EC, Cahen DL, Koch AD, Braat H, Poley JW, Kuipers EJ, Bruno MJ. The prevalence of fat-soluble vitamin deficiencies and a decreased bone mass in patients with chronic pancreatitis. Pancreatology. 2013 May-Jun;13(3):238-42. doi: 10.1016/j.pan.2013.02.008. Epub 2013 Mar 4.
PubMed 23719594Mann ST, Stracke H, Lange U, Klor HU, Teichmann J. Vitamin D3 in patients with various grades of chronic pancreatitis, according to morphological and functional criteria of the pancreas. Dig Dis Sci. 2003 Mar;48(3):533-8. doi: 10.1023/a:1022540816990.
PubMed 12757166
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Disease in Chronic Pancreatitis: A Complex Phenomenon
- ClinicalTrials.gov ID
- NCT02108509
- Acronym / sponsor ID
- 0113-14-FB
- Conditions
- Chronic Pancreatitis, Osteopenia, Osteoporosis
- Keywords
- Chronic Pancreatitis, Osteopenia, Osteoporosis, Hypogonadism, Opioid medications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 5 May 2014 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- The outcome measures include:
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both males and females with diagnosis of chronic pancreatitis
Key inclusion criteria (2 listed)
- Age 19-75 years
- Diagnosis of Chronic Pancreatitis, as defined by specific clinical criteria
Key exclusion criteria (2 listed)
- Refusal to complete the consent process in it's entirety.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Prevalence of hypogonadism in patients with chronic pancreatitis.
Time frame: Single time point (at time of data collection)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 20125091Yadav D, Whitcomb DC. The role of alcohol and smoking in pancreatitis. Nat Rev Gastroenterol Hepatol. 2010 Mar;7(3):131-45. doi: 10.1038/nrgastro.2010.6. Epub 2010 Feb 2.
- Background: PubMed 21946280Yadav D, Timmons L, Benson JT, Dierkhising RA, Chari ST. Incidence, prevalence, and survival of chronic pancreatitis: a population-based study. Am J Gastroenterol. 2011 Dec;106(12):2192-9. doi: 10.1038/ajg.2011.328. Epub 2011 Sep 27.
- Background: PubMed 23622135Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
- Background: PubMed 21792080Nusrat S, Yadav D, Bielefeldt K. Pain and opioid use in chronic pancreatitis. Pancreas. 2012 Mar;41(2):264-70. doi: 10.1097/MPA.0b013e318224056f.
- Background: PubMed 22593477Klapdor S, Richter E, Klapdor R. Vitamin D status and per-oral vitamin D supplementation in patients suffering from chronic pancreatitis and pancreatic cancer disease. Anticancer Res. 2012 May;32(5):1991-8.
- Background: PubMed 24419292Targownik LE, Bernstein CN, Leslie WD. Risk factors and management of osteoporosis in inflammatory bowel disease. Curr Opin Gastroenterol. 2014 Mar;30(2):168-74. doi: 10.1097/MOG.0000000000000037.
- Background: PubMed 24290593Krupa-Kozak U. Pathologic bone alterations in celiac disease: etiology, epidemiology, and treatment. Nutrition. 2014 Jan;30(1):16-24. doi: 10.1016/j.nut.2013.05.027.
- Background: PubMed 20739891Haworth CS. Impact of cystic fibrosis on bone health. Curr Opin Pulm Med. 2010 Nov;16(6):616-22. doi: 10.1097/MCP.0b013e32833e2e94.
- Background: PubMed 10811020Haaber AB, Rosenfalck AM, Hansen B, Hilsted J, Larsen S. Bone mineral metabolism, bone mineral density, and body composition in patients with chronic pancreatitis and pancreatic exocrine insufficiency. Int J Pancreatol. 2000 Feb;27(1):21-7. doi: 10.1385/IJGC:27:1:21.
- Background: PubMed 18824882Dujsikova H, Dite P, Tomandl J, Sevcikova A, Precechtelova M. Occurrence of metabolic osteopathy in patients with chronic pancreatitis. Pancreatology. 2008;8(6):583-6. doi: 10.1159/000159845. Epub 2008 Sep 29.
- Background: PubMed 21742614Sudeep K, Chacko A, Thomas N, Selvakumar R, George B, Paul TV, Seshadri MS. Predictors of osteodystrophy in patients with chronic nonalcoholic pancreatitis with or without diabetes. Endocr Pract. 2011 Nov-Dec;17(6):897-905. doi: 10.4158/EP10410.OR.
- Background: PubMed 21441842Joshi A, Reddy SV, Bhatia V, Choudhuri G, Singh RK, Singh N, Bhatia E. High prevalence of low bone mineral density in patients with tropical calcific pancreatitis. Pancreas. 2011 Jul;40(5):762-7. doi: 10.1097/MPA.0b013e31821396b2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Boerner, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Osteopenia, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02108509, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.