Analysis of Bone Quality in Adult Patients With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases; Osteoporosis
MeSH terms: Osteoporosis; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

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.
    

Detailed 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).

      HYPOTHESES OF THE STUDY Subjects with inflammatory bowel disease present an alteration in
      bone quality that can be assessed by TBS, with TBS values expected to be lower than those of
      subjects without IBD or known bone pathology, with a decrease of up to 50 points in this
      parameter.

      Primary Objective : to evaluate and compare the values of the trabecular bone score (TBS), a
      surrogate marker of bone quality, in patients with inflammatory bowel disease (IBD) and in a
      control group of volunteers without IBD or known metabolic bone pathology, recruited in the
      consultations of the Endocrinology and Nutrition, Digestive System and Rheumatology
      departments of the Hospital Ruber Juan Bravo during routine health control visits, adjusted
      for age, sex and body mass index (BMI).

      Secondary Objectives

        1. To compare bone mineral density (BMD) values measured by dual energy X-ray
           absorptiometry (DXA) at the lumbar spine (anteroposterior and lateral) and proximal
           femur in patients with IBD with those of a control group of subjects adjusted for age,
           sex and BMI.

        2. To compare the ultrasound velocity and attenuation parameters (BUA and SOS) obtained by
           quantitative ultrasound of the calcaneus (QUS) in patients with IBD with those of a
           control group of subjects adjusted for age, sex and BMI.

        3. To analyse the prevalence and severity of vertebral fractures using the Vertebral
           Fracture Assessment (VFA) software of lateral DXA in patients with IBD compared to a
           control group adjusted for age, sex and BMI.

        4. To correlate the TBS results with the ultrasound velocity and attenuation parameters
           (BUA and SOS) obtained with QUS.

        5. To correlate TBS results with BMD parameters measured by DXA in the lumbar spine
           (anteroposterior and lateral) and in the proximal femur.

        6. To compare biochemical markers of bone remodelling [carboxy-terminal telopeptide of type
           I collagen (ß-CTx Crosslaps) and N-terminal propeptide of type I protocolagen (P1NP)] in
           patients with IBD with a control group of subjects adjusted for age, sex and BMI.

        7. To correlate baseline levels of biochemical markers of bone remodelling with the results
           of: a) BMD obtained with DXA in the lumbar spine (anteroposterior and lateral) and in
           the proximal femur, b) TBS values and c) parameters obtained with QUS.

        8. To assess the absolute 10-year risk of major fractures and hip fractures using the FRAX
           tool, in subjects with IBD. To correlate the absolute risk of fractures with the TBS and
           QUS values.

        9. To evaluate the effect of adjusting the FRAX tool by including TBS values for the
           calculation of the absolute risk of major and hip fractures.

       10. To analyse the evolution of bone microarchitecture parameters measured by TBS, bone
           ultrasound parameters of ultrasound velocity and attenuation, BMD in the lumbar spine
           (anteroposterior and lateral) and in the proximal femur and biochemical markers of bone
           remodelling in patients with IBD after one year of follow-up.

       11. To analyse the discriminative capacity for the diagnosis of vertebral fractures
           evaluated with VFA of the TBS and QUS values, compared with the BMD values obtained in
           lumbar DXA (anteroposterior and lateral) in patients with IBD.

       12. To compare volumetric BMD parameters measured by 3D bone densitometry (DXA-3D) of the
           hip in patients with IBD with a control group of subjects adjusted for age, sex and BMI.

       13. To correlate bone quality parameters measured by TBS and QUS with volumetric BMD
           measured by 3D DXA-3D in the hip.

       14. To evaluate the effect of the different disease-modifying treatments (biologicals,
           corticoids, etc.) on TBS values, bone ultrasound parameters, BMD values by conventional
           DXA and DXA-3D in patients with IBD.

      This study is organised into two sub-studies:

        -  Sub-study 1: observational, analytical, prospective, cross-sectional. Cohort-type study,
           with a cohort of patients with IBD and a cohort of volunteers without IBD or known
           metabolic bone pathology, recruited in the consultations of the Endocrinology and
           Nutrition, Digestive System and Rheumatology departments of the Ruber Juan Bravo
           Hospital during routine health control visits, adjusted for age, sex and body mass index
           (BMI). The baseline data on bone quality measured by: a) bone densitometry in the lumbar
           spine (anteroposterior and lateral), b) bone densitometry in the proximal femur, c) TBS,
           d) DEXA-3D, e) calcaneal ultrasound, e) fractures assessed by VFA and f) biochemical
           markers of bone remodelling in both cohorts will be analysed to respond to the primary
           objective, secondary objectives 2 to 9 and exploratory objectives 11 to 14.

        -  Sub-study 2: observational, analytical, prospective and longitudinal, with one-year
           follow-up of IBD patients only. Bone quality parameters measured by: a) bone
           densitometry in the lumbar spine (anteroposterior and lateral), b) bone densitometry in
           the proximal femur, c) TBS, d) DEXA-3D, e) calcaneal ultrasound, e) fractures assessed
           by VFA and f) biochemical markers of bone remodelling will be analysed to respond to
           secondary objective 10.
    

Intervention name(s): Densitometry with Trabecular Bone Score; Quantitative Ultrasound of Calcaneus; Laboratory test
Intervention type(s): Other; Other; Other
Intervention description(s): 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.; Quantitative bone ultrasound of calcaneus evaluated with a SONOST 3000, (OsteoSys Co, Korea).; 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).
Other intervention name(s): General Electric Prodigy Advance Full enCORE version 11.x; Sonost 3000
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of the Endocrinology and Nutrition, Digestive System and Rheumatology departments
        of the Ruber Juan Bravo Hospital,