Trial document




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  DRKS00009841

Trial Description

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Title

Long-term observational study to assess the development of Endocrine late effects and Osteopathologies in juvenile survivors of Paediatric Malignancies

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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

Many survivors of pediatric malignancies develop endocrine late effects, including impaired bone health, stemming from cancer and cancer treatment. Endocrine late effects, and especially an impairment of bone health, may occur early after the initial diagnosis, and thus affect children and adolescents. With the study ‘BONE-OK?’ we investigate the hormonal system with a focus on bone health during yearly follow-up visits. Additionally, patients are asked to answer a questionnaire regarding life style parameters and quality of life. We aim to investigate the time course of the development of impaired bone health and develop prevention strategies for survivors of pediatric malignancies

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Brief Summary in Scientific Language

This survey is a follow-up study to the cross-sectional study: “Investigations of bone health of survivors of childhood malignoma”.
During this first cross-sectional study the effects of childhood cancer and cancer therapy on endocrine function and bone health were investigated in 586 patients starting April 2012.
To assess bone health, a thorough analysis of clinical parameters, laboratory test results, including parameters of bone metabolism and a survey regarding dietary and life style parameters was performed. The information on treatment (including cumulative doses of chemotherapy, glucocorticoids and ionized radiation) were collected from the patient files. A bone density scan by osteodensitometry (DXA) was performed in patients with increased risk of osteopenia (bone pain, noticeable laboratory values).
The initial study revealed an unexpected high proportion of osteopathologies and endocrine late effects in survivors, which necessitated the development of therapy-algorithms for the frequent vitamin D deficiency and secondary hyperparathyroidism in this population.
Furthermore, multidisciplinary rounds with pediatric endocrinologists and pediatric oncologists were established on a weekly basis for the participating patients. Since osteopathologies are difficult to identify in children and adolescents, we developed an 8 -point-score (BPH), which reflects clinical, hormonal and radiological findings, and increases pathological results.
The present study was initiated to obtain follow-up data on the patients of the initial study and to include additional survivors for a long term period.
We aim to answer the following questions:
a) What is the natural cause of osteopathologies in survivors of childhood malignancies over time?
b) Are confounding factors of cancer and cancer therapy on osteopathologies identifiable?
c) Does the early detection and therapy of a vitamin D deficiency improve bone health in this cohort over time?

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Organizational Data

  •   DRKS00009841
  •   2016/03/21
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  •   yes
  •   Approved
  •   15-6278-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   U1111-1179-9374 
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Health Condition or Problem studied

  •   C00-D48 -  Neoplasms
  •   E00-E90 -  Endocrine, nutritional and metabolic diseases
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Interventions/Observational Groups

  •   Observation of bone health and the functioning of the endocrine system.
    Therefore implementation of a selective clinical examination, laboratory testing of the parameters of bone metabolism in blood and urine and selective dietary and movement anamnesis by questionnaire.
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Characteristics

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

Bone Health and Osteopathologies, as assessed by a score based on biochemical, radiological and clinical data.
Annual health checks within the regulary after-care. The health checks are planned for a period of 5 years.

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Secondary Outcome

Development of endocrine late effects.
Annual health checks within the regulary after-care. The health checks are planned for a period of 5 years.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/02/22
  •   1500
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Survivors of childhood cancer after completing the intensive care/therapy

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Pädiatrische Hämatologie und OnkologieKlinik für Kinderheilkunde IIIUniversitätsklinikum Essen
    • Mr.  Dr. med.  Michael  Schündeln 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Pädiatrische Endokrinologie und DiabetologieKlinik für Kinderheilkunde IIUniversitätsklinikum Essen
    • Ms.  PD Dr. med.  Corinna  Grasemann 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Pädiatrische Endokrinologie und DiabetologieKlinik für Kinderheilkunde IIUniversitätsklinikum Essen
    • Ms.  Daniela   Polansky 
    • 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.