Analysis of Bone Quality in Adult Patients With Inflammatory Bowel Disease

NCT05171153 | Completed

• 1 other identifier: PIC108-21_HRJB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Trabecular Bone Score

  Trabecular bone score

  1 year

Secondary Outcomes (5)

• BMD

  1 year

• BQI

  1 year

• VFA

  1 year

• ß-CTx

  1 year

• P1NP

  1 year

Other Outcomes (1)

• Volumetric BMD

  1 year

Study Arms (2)

IBD group

Subjects over 21 years old, with inflammatory bowel disease (both ulcerative colitis and Crohn's disease), diagnosed by clinical, biochemical, endoscopic and anatomo-pathological criteria.

Other: Densitometry with Trabecular Bone Score; Other: Quantitative Ultrasound of Calcaneus; Other: Laboratory test

Control group

Subjects over 21 years old, without IBD or known metabolic bone disease, recruited voluntarily in the Endocrinology and Nutrition, Digestive System and Rheumatology departments of the Ruber Juan Bravo Hospital, during routine health control visits

Other: Densitometry with Trabecular Bone Score; Other: Quantitative Ultrasound of Calcaneus; Other: Laboratory test

Interventions

Densitometry with Trabecular Bone Score OTHER

Conventional bone densitometry at the level of the proximal femur and lumbar spine (L1-L4) (anteroposterior and lateral) measured with a General Electric Prodigy Advance Full enCORE version 11.x equipment. With the data from the lateral densitometry, and using the "VFA Dual Vertebral Assessment H8650DA/DM" software, a quantitative morphometric analysis of the thoracolumbar vertebrae (T4-L4) will be carried out. Additionally, microarchitectural parameters of the lumbar spine will be evaluated with TBS (iNsight v3.0) and bone quality in the proximal femur with the DEXA-3D 3D-SHAPER v2.10.1 software. Vertebral fracture will be excluded from the DXA and TBS analysis of the spine.

Also known as: General Electric Prodigy Advance Full enCORE version 11.x

Control group; IBD group

Quantitative Ultrasound of Calcaneus OTHER

Quantitative bone ultrasound of calcaneus evaluated with a SONOST 3000, (OsteoSys Co, Korea).

Also known as: Sonost 3000

Control group; IBD group

Laboratory test OTHER

Analysis of general biochemical parameters and serum phospho-calcium metabolism, including: total calcium, albumin, phosphorus, 25-OH-vitamin D, intact PTH (iPTH), creatinine, estimated glomerular filtration rate, carboxy-terminal telopeptide of type I collagen ß-CTx (Crosslaps) and N-terminal propeptide of type I procollagen (P1NP).

Control group; IBD group

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Endocrinology and Nutrition, Digestive System and Rheumatology departments of the Ruber Juan Bravo Hospital,

You may qualify if:

• Subjects over 21 years old, with inflammatory bowel disease (both ulcerative colitis and Crohn's disease), diagnosed by clinical, biochemical, endoscopic and anatomo-pathological criteria.
• Subjects over 21 years old, without IBD or known metabolic bone pathology, recruited voluntarily in the Endocrinology and Nutrition, Digestive System and Rheumatology departments of the Ruber Juan Bravo Hospital, during routine health control visits (control group).
• Subjects without language barriers, who expressed their willingness to cooperate in the follow-up and who gave their informed consent before entering the study.

You may not qualify if:

• Other concomitant causes of metabolic bone disease: Paget's disease, severe chronic renal insufficiency (estimated glomerular filtration rate \<30 ml/min/1.73m2), metastatic bone disease, multiple myeloma, Hypercalcemia \> 11 mg/dl, period of immobilisation for more than 3 months in the previous year.
• Pregnant women or women planning pregnancy during the recruitment and testing process.
• Anatomical alteration of the right foot that may interfere with calcaneal ultrasound, including moderate-severe edema.
• Patients on active treatment with antiresorptive drugs, osteoformers, or pharmacological doses (\>50,000 units/month) of vitamin D3 (cholecalciferol).
• Patients with a history of treatment with oral bisphosphonates, strontium ranelate or therapeutic doses of fluoride (\>20 mg/day) for more than 3 months in the two years prior to the baseline visit, or for more than two years at any time in their life.
• Patients who have received an intravenous bisphosphonate in the three years prior to the baseline visit.
• Patients who have received denosumab within 6 months prior to the baseline visit.
• Patients who have received calcitonin or a selective oestrogen receptor modulator in the 3 months prior to the baseline visit.
• Participation at the time of recruitment in a clinical trial with medicinal products for the prevention or treatment of osteoporosis and/or IBD.
• Chronic diseases affecting bone metabolism, for example, active hyperthyroidism within the last 6 months, Cushing's syndrome, anorexia nervosa, early menopause, type 1 diabetes mellitus, poorly controlled type 2 diabetes mellitus of more than 5 years' duration or with microvascular complications, or primary hyperparathyroidism.
• Active treatment with drugs that affect bone quality such as corticoids, oral anticoagulants, anti-estrogens (aromatase inhibitors and/or GnRH analogues), anti-androgens and anti-retroviral

Sponsors & Collaborators

• Quironsalud: lead

Study Sites (1)

Hospital Ruber Juan Bravo

Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Osteoporosis

Interventions

Densitometry; Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Maria Cortes

  Quironsalud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinology MD

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 28, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)