Trial document




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  DRKS00000036

Trial Description

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Title

A Randomized Open Clinical Study of Daily Subcutaneous Teriparatide Injection on the Consolidation of Regenerated Bone Formed after Distraction Osteogenesis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study is conducted in patients who suffered from bone loss due to infection and were treated with bone segment transport. It will be assessed whether the treatment with teriparatid (parathyroid hormone) accelerates stiffness and weight bearing capacity of the newly formed bone compared to not receiving this treatment.

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Brief Summary in Scientific Language

A randomized open monocenter study in patients after bone resection due to osteomyelitis that were treated with distraction osteogenesis. It will be assessed whether the treatment with teriparatid increases bone mineral densitiy and improves biomechanical properties.

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Organizational Data

  •   DRKS00000036
  •   2008/09/25
  •   [---]*
  •   yes
  •   Approved
  •   08041, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   2008-000592-24 
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Health Condition or Problem studied

  •   tibial bone loss
  •   M86 -  Osteomyelitis
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Interventions/Observational Groups

  •   Visit 1: Two days after "docking" informed consent will be obtained. Medical history, a clinical investigation and a laboratory analysis are performed. A dexa scan and biomechanical testing will be done. The study medication will be dispensed.
    Visit 2: After 4 weeks a clinical control visit and laboratory analysis are performed.
    Visit 3. After 8 weeks a Dexa scan, biomechanical testing and a laboratory analysis are performed again. The study medication will be returned and compliance will be checked.
    Visit 4: After 16 weeks a Dexa scan, biomechanical testing and a laboratory analysis are performed again.
    Visit 5: After 12 month the functional outcome will be assessed by standard functional outcome tests.
  •   Visit 1: Two days after "docking" informed consent will be obtained. Medical history, a clinical investigation and a laboratory analysis are performed. A dexa scan and biomechanical testing will be done.
    Visit 2: After 4 weeks a clinical control visit and laboratory analysis are performed.
    Visit 3. After 8 weeks a Dexa scan, biomechanical testing and a laboratory analysis are performed again. The study medication will be dispensed.
    Visit 4: After 16 weeks a Dexa scan, biomechanical testing and a laboratory analysis are performed again. The study medication will be returned and compliance is checked.
    Visit 5: After 12 month the functional outcome will be assessed by standard functional outcome tests.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Crossover
  •   III
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Primary Outcome

Bone mineral density assessed by DEXA scan

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Secondary Outcome

Load / Share Ratio by biomechanical testing || Functional Outcome Score

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2008/09/15
  •   16
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Inclusion Criteria

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

Bone segment transport and lengthening performed
Signed Informed Consent

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Exclusion Criteria

Diabetes mellitus
Malignancies
Prior radiation therapy of the skeleton
Active infection
Severe deformities
Hyper - or hypoparathyroidism
Pre-existing hypercalcemia
Complications during surgery and lengthening period
Renal stones
Liver function disorder
Renal failure
Paget's disease
Alcohol or Drug dependence
Pregnancy or breast feeding

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Addresses

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    • Sponsor ist die Institution der Berufsgenossenschaftlichen Unfallklinik Murnau Ärztlicher Direktor
    • Mr.  Prof. Dr. med.  Volker  Bühren 
    • Professor - Küntscher - Str. 8
    • 82414  Murnau
    • Germany
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    •   08841 - 480
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    • Berufsgenossenschaftliche Unfallklinik Murnau
    • Ms.  Dr. med.  Silke  Keiser 
    • Prof. Küntscher Str. 8
    • 82414  Murnau
    • Germany
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    • Berufsgenossenschaftliche Unfallklinik Murnau
    • Mr.  Dr. med.  Henrik  Eckardt 
    • Professor-Küntscher-Str. 8
    • 82418  Murnau
    • Germany
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Sources of Monetary or Material Support

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    • Lilly Deutschland GmbH
    • Werner-Reimers-Straße 2-4
    • 82418  Bad Homburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/07/14
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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.