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NCT05171153

Analysis of Bone Quality in Adult Patients With Inflammatory Bowel Disease

Completed Last updated 18 November 2023
What this trial tests

trial testing Densitometry with Trabecular Bone Score in Inflammatory Bowel Diseases in 100 participants. Completed in 1 January 2023.

Timeline
1 October 2021
Primary endpoint
1 December 2022
1 January 2023

Quick facts

Lead sponsorQuironsalud
StatusCompleted
Study typeOBSERVATIONAL
Enrollment100
Start date1 October 2021
Primary completion1 December 2022
Estimated completion1 January 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Quironsalud

Who can join

Adults 21 to 100, any sex, with Inflammatory Bowel Diseases or Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Inflammatory bowel disease (IBD) is considered a risk factor for the development of osteoporosis, which leads to an increased risk of fractures. There is no data on bone quality obtained with imaging techniques other than bone densitometry such as Trabecular Bone Score (TBS), 3D bone densitometry (DXA-3D) or quantitative bone ultrasound (QUS). The TBS study can provide information on bone microarchitecture in these patients, with TBS values expected to be lower than those of subjects without IBD, with a decrease of up to 50 points in this parameter. Primary objective: to evaluate and compare TBS values in patients with IBD and in a control group of volunteers without IBD or known metabolic bone pathology, adjusted for age, sex and body mass index (BMI). Secondary objectives: to evaluate and compare results in DEXA parameters, QUS, DEXA-3D, biochemical parameters and FRAX data between patients with IBD and controls. To evaluate the prevalence of vertebral fractures analyzed by VFA. As well as to evaluate the evolution in one year of all these parameters in patients with IBD. Prospective observational study with a cohort of patients with IBD and another of volunteers without IBD or metabolic bone pathology, adjusted for age, sex and BMI. Baseline bone quality data will be analyzed by bone densitometry, TBS, DEXA-3D and QUS, fractures assessed by VFA and bone remodeling markers in both cohorts. Subsequently, a one-year analysis of the parameters of the IBD cohort will be performed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Inflammatory Bowel Diseases

Currently open trials in the same condition.

Other Quironsalud trials

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Data sources for this page

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