- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06600334
Prevalence of Osteoporosis Among Inflammatory Bowel Disease Patients in Assiut University Hospitals
September 16, 2024 updated by: Dina Fathy
the prevalence of osteoporosis in patients with inflammatory bowel disease in Assiut University Hospitals.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Inflammatory bowel disease (IBD) includes ulcerative colitis (UC) and Crohn's disease (CD) (1) .There has been a global rise in the incidence of IBD over the last few decades.
(2) In the course of this disease, apart from the involvement of the gastrointestinal tract, up to 50% of patients may also have extraintestinal manifestations (EIMs) .One of them may be osteoporosis (OST), which is present in over half of IBD patients; this constitutes a significant problem due to the increased risk of fractures, especially non-traumatic fractures.(3)
Known risk factors for OST in IBD include the persistence of chronic inflammation, treatment with glucocorticosteroids, extensive range of the disease, previous resection of the small intestine, arthralgia, and current nutritional deficiencies.
Some risk factors are similar to those found in the general population, such as age, smoking, or low physical activity.(3)
The pathogenesis of osteoporosis is multifactorial and comprises such elements as steroid therapy, low body mass index (BMI), malnutrition, genetic predispositions, and vitamin D deficiency (4) Given that the gastroenterologist is often regarded as the main provider for IBD patients, gastroenterologists and primary care physicians are equally responsible to recommend preventive measures and screening for osteoporosis, in addition to other healthcare maintenance issues.(5)
Dual energy X-ray absorptiometry (DEXA) scans are globally recognised as the screening tool for low BMD (6) The Z and T scores are used to establish the diagnosis of osteoporosis, osteopenia or low BMD according to the 2019 International Society of Clinical Densitometry official position for adults.(7)
Study Type
Observational
Enrollment (Estimated)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dina Fathy Abd ElMawgod
- Phone Number: +201067112860
- Email: dina59224@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
cases of IBD in Internal medicine department, Assiut University Hospitals.
Description
Inclusion Criteria:
- The study will include Patients aged 18-65 years, diagnosed with either Crohn's disease or ulcerative colitis, The diagnosis of UC and CD based on the clinical, endoscopic, laboratory and histological criteria according to ECCO Guidelines. The activity of IBD will be determined with the use of the Crohn's Disease Activity Index (CDAI) for CD, and the Mayo score for UC, data collection will obtained over one year duration
Exclusion Criteria:
- Patients Known to have osteoporosis and on treatment
- Female patients on COCs
- Patients with malignancy
- Patients with CKD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
1- To detect the prevalence of osteoporosis in patients with inflammatory bowel disease in Assiut University Hospitals.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lewandowski K, Kaniewska M, Wiecek M, Szwarc P, Panufnik P, Tulewicz-Marti E, Walicka M, Franek E, Rydzewska G. Risk Factors for Osteoporosis among Patients with Inflammatory Bowel Disease-Do We Already Know Everything? Nutrients. 2023 Feb 24;15(5):1151. doi: 10.3390/nu15051151.
- Frisoli A Jr, Paes AT, Kimura AD, Azevedo E, Ambrosio V. Measuring forearm bone density instead of lumbar spine bone density improves the sensitivity of diagnosing osteoporosis in older adults with cardiovascular diseases: Data from SARCOS study. Bone Rep. 2021 Oct 4;15:101134. doi: 10.1016/j.bonr.2021.101134. eCollection 2021 Dec.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
September 13, 2024
First Submitted That Met QC Criteria
September 16, 2024
First Posted (Estimated)
September 19, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 16, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- osteoporosis and IBD patients
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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