Trial document




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  DRKS00003636

Trial Description

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Title

Bonehealth in children and adolescents with hematologic/oncologic diseases

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Trial Acronym

Bone OK

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The impact of chemotherapy and oncologic/hematologic disease on bone health in the pediatric population is analysed. Aim of the study is to isolate risk factors and predictive markers.
All survivors of malignant diseases aswell as patients with certain hematologic diseases (e.g. sickle cell disease) are invited to participate. We are interested in the question whether life style parameters (such as diet, sports etc.) correlate with the outcome of bone health. Also we are planning to compare some "new" markers of bone metabolism (such as osteocalcin) with established markers of bone health.

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Brief Summary in Scientific Language

Aim of the study is to investigate the impact of chemotherapy and oncologic/hematologic disease on bone health. The study is aimed to find risk factors and predictive markers.

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Organizational Data

  •   DRKS00003636
  •   2012/08/28
  •   [---]*
  •   yes
  •   Approved
  •   12-4966-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   complete spectrum of paediatric oncologic diseases.
    chronic haematological diseases (sickle cell, thalassemia)
  •   C00-C97 -  Malignant neoplasms
  •   D55-D59 -  Haemolytic anaemias
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Interventions/Observational Groups

  •   Aim of the study is to investigate the impact of chemotherapy and oncologic/hematologic disease on bone health. As part of the visit the patient will undergo a thorough physical examination. We will measure routine bone parameters (such as Vitamine D, Ca. PTH), each participant will fill out a questionnaire regarding diet, pain and exercise. The blood test for the study includes "non-routine" parameters such as osteocalcin.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Risk of osseous morbidity in cancer survivors
Risk of osseous morbidity in patients with chronic haematological disease

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Secondary Outcome

Influence of life style parameters on bone health.
correlation of osteocalcin levels and osseous morbidity.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2012/09/01
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Years
  •   18   Years
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Additional Inclusion Criteria

oncologic/hematologic disease

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Exclusion Criteria

symptomatic anemia

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Addresses

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    • Abteilung für Hämatologie und Onkologie Kinderklinik III Universitätsklinikum Essen
    • Ms.  Professor  Angelika  Eggert 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Oberarzt Abteilung für Hämatologie und Onkologie Kinderklinik III Universitätsklinikum Essen
    • Mr.  Dr. med.  Michael  Schündeln 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Oberarzt Abteilung für Hämatologie und Onkologie Kinderklinik III Universitätsklinikum Essen
    • Mr.  Dr. med.  Michael  Schündeln 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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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.