Trial document




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  DRKS00013028

Trial Description

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Title

Evaluation of metabolic bone disease and fracture prevalence in patients with Crohn’s disease

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Trial Acronym

CROHN-BONE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Bone metabolic disease is a common, but often underestimated, complication of Crohn's disease and can be associated with an increased bone fracture risk.
Previous studies on the frequency of bone metabolic disorders in patients with chronic inflammatory diseases varied with the investigated population.
The aim of the study is to investigate which patients have an increased risk of bone loss (osteoporosis) and bone fractures. This is to be achieved by determining the frequency of osteoporosis and fractures in a representative cohort of Crohn's disease patients and by identifying clinical and biological factors associated with low bone density and fractures.
It is planned to perform a prospective cross-sectional study with Crohn's disease patients and healthy controls.

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Brief Summary in Scientific Language

Bone metabolic disease is a common but often underestimated complication of Crohn's disease and can be associated with an increased bone fracture risk. The underlying pathophysiology has not been clarified. Several factors such as disease-related inflammatory, malabsorption, glucocorticoid therapy and hypogonadism can contribute to bone loss.
Previous studies on the frequency of bone metabolic disorders in patients with chronic inflammatory bowel disease vary with the population studied.
Bone mineral density measurement is a method often used in clinical practice to detect osteoporotic changes and to assess bone fracture risk.
The aim of the study is to investigate which patients have an increased risk of bone loss (osteoporosis) and bone fractures. The incidence of osteoporosis and fractures in a representative cohort of Crohn's disease patients and the identification of clinical and biological factors associated with low bone density and fractures will be assessed.
It is planned to conduct a prospective cross-sectional study with Crohn's disease patients and healthy controls.

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Organizational Data

  •   DRKS00013028
  •   2017/09/14
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  •   yes
  •   Approved
  •   16-252-1216, Ethikkommission der Stadt Wien Thomas-Klestil-Platz 8/2 1030, Wien
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Secondary IDs

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Health Condition or Problem studied

  •   K50.9 -  Crohn disease, unspecified
  •   M82 -  Osteoporosis in diseases classified elsewhere
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Interventions/Observational Groups

  •   Patients with Crohn's disease:
    Bone density is measured by means of DXA and by means of questionnaires (age, weight, etc.). Clinical activity index in Crohn's disease (CDAI), lab parameters (biochemistry profile, malabsorption relevant markers, blood count, bone metabolism relevant hormones and vitamins, inflammation parameters, stool analysis, bone metabolism markers) ), which patients have an increased risk of bone loss (osteoporosis) and bone fractures.
  •   Healthy Controls. Control subjects will be recruited from a preventive medical examination program. Laboratory parameters will be determined for comparison with the Crohn patients (inflammation markers, stool analysis, bone metabolism markers).
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Bone Mineral Density by DXA (only in patients with Crohn's disease)

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Secondary Outcome

Questionnaires (Age, weight, height,CD diagnosis date and history, Gender, Current and preceding medications, Comorbidities, Fracture history in 1st degree relatives, Smoking and Alcohol status, Number of flare-ups requiring a visit to the physician and/or corticosteroid use during the preceding year, Lifestyle factors including, history of fractures, BMI, and dietary factors, OSTEO-CHECK and IBDQ-D questionnaire), CDAI (Crohn's Disease Activity Index), lab parameters (biochemistry profile, Malabsorbtion testing, blood count,
Bone metabolism relevant hormones and vitamins, inflammatory parameters, Stool analysis, Bone metabolism markers)

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2017/09/14
  •   218
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with Crohn´s disease at least 18 years old

Control subjects will be recruited from a preventive medical examination program.

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Exclusion Criteria

• Critically or terminally ill patients.
• Unable to comply with study protocol.
• Pregnancy (positive urine pregnancy test)

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Addresses

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    • Ludwig Boltzmann Institut für Osteologie
    • Mr.  Dr.  Klaus  Klaushofer 
    • Heinrich Collin-Str. 30
    • 1140  Wien
    • Austria
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    • Ludwig Boltzmann-Institut für Osteologie
    • Mr.  Dr.  Jochen  Zwerina 
    • Heinrich Collin-Str. 30
    • 1140  Wien
    • Austria
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    • Ludwig Boltzmann-Institut für Osteologie
    • Mr.  Dr.  Johann  Bartko 
    • Heinrich Collin-Str. 30
    • 1140  Wien
    • Austria
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Sources of Monetary or Material Support

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    • Ludwig Boltzmann-Institut für Osteologie
    • Mr.  Dr.  Klaus  Klaushofer 
    • Heinrich Collin-Str. 30
    • 1140  Wien
    • Austria
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.