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NCT05171153
Analysis of Bone Quality in Adult Patients With Inflammatory Bowel Disease
trial testing Densitometry with Trabecular Bone Score in Inflammatory Bowel Diseases in 100 participants. Completed in 1 January 2023.
1 December 2022
Quick facts
| Lead sponsor | Quironsalud |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 October 2021 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 January 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Densitometry with Trabecular Bone Score
- Quantitative Ultrasound of Calcaneus
- Laboratory test
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Osteoporosis — all drugs for Osteoporosis →
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.
Verify or expand the search:
- PubMed search for NCT05171153
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Quironsalud trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05171153 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Quironsalud
- Last refreshed: 18 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05171153.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing