Trial document




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  DRKS00009411

Trial Description

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Title

Treatment of Medication-related osteonecrosis of the jaw: a clinical examination

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

By examining surgically treated MRONJ-patients, wa aim at investigating possible triggering factors for complications in the post therapeutic course of the disease.
We want to put focus on whether the different pharmacological mode of action of Bisphosphonates and RANKL-antibody Denosumab has any effects on differences in post-therapeutic course.

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Organizational Data

  •   DRKS00009411
  •   2016/10/13
  •   [---]*
  •   yes
  •   Approved
  •   306/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   M87.18 -  [generalization M87.1: Osteonecrosis due to drugs]
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Interventions/Observational Groups

  •   Follow-up examination of patients who unterwent surgery for Medication-Related Osteonecrosis of the Jaws, related to treatment with either bisphosphonates, Denosumab or bisphosphonates and Denosumab.
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Characteristics

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

Percentage of patients with recurrent MRONJ after treatment.

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Secondary Outcome

Effect of given antiresorptive agent - Bisphosphonates, Denosumab, Bisphosphonates and Denosumab - on:
- likeliness of development of recurrent MRONJ
- clinical stage of present MRONJ
- post-therapeutic course

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/10/26
  •   200
  •   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 of the department of oral- and maxillofacial surgery who have been diagnosed with MRONJ, according to the definition of AAOMS, and therefore were treated surgically.

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Exclusion Criteria

Patients with a history of radiation to the jaws or obvious metastatic disease to the jaws

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Pit Jacob  Voss 
    • Hugstetter Straße 55
    • 79106  Freiburg im Breisgau
    • Germany
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    • Klinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Pit Jacob  Voss 
    • Hugstetter Straße 55
    • 79106  Freiburg im Breisgau
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Klinik für Mund-, Kiefer- und Gesichtschirurgie
    • Mr.  Dr. Dr.  Pit Jacob  Voss 
    • Hugstetter Straße 55
    • 79106  Freiburg im Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Mund-, Kiefer- und Gesichtschirurgie Freiburg
    • Hugstetter Straße 55
    • 79106  Freiburg im Breisgau
    • 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.