Trial document





This trial has been registered retrospectively.
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  DRKS00013233

Trial Description

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Title

Sequential activation of the AKT pathway in human osteoblasts treated with Oscarvit: a bioactive product with positive effect both on skeletal pain and mineralization in osteoblasts

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aims of the study are: (i) to prove a possible positive effect of oscarvit (OSC) on patient's bone pain, (ii) to analyse the effect of OSC on the expression of osteoblast-specific genes and proteins which play an important role in bone development, (iii) to measure the effect of OSC on calcium content in osteoblasts, and (iiii) to analyse whether OSC has any influence on signal transduction pathways in osteoblasts.



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Brief Summary in Scientific Language

Oscarvit (OSC) is an in-house preparation consisting of minerals and naturally occurring glycosaminoglycans. OSC has been used to analyze its effect on pain associated with bone diseases and in vitro in osteoblasts.
OSC, 0.6 g three times daily, resulted in significant positive effect on pain alleviation of 68% after 20 days. In in-vitro cultivated osteoblasts significant overexpression of osteocalcin, osteopontin , bone sialoprotein, and dentin matrix phosphoprotein genes could be detected when compared to control osteoblasts. OSC-treated osteoblasts produced vast extracellular calcium deposits. In addition OSC promotes osteoblasts differentiation and activates the AKT signaling pathway.

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Organizational Data

  •   DRKS00013233
  •   2017/11/06
  •   [---]*
  •   yes
  •   Approved
  •   D475/14, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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

  •   M80 -  Osteoporosis with pathological fracture
  •   M81 -  Osteoporosis without pathological fracture
  •   M82 -  Osteoporosis in diseases classified elsewhere
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Interventions/Observational Groups

  •   Oscarvit, 3x600 mg/day, for 20 days
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

After 20 days treatment with OSC (3x600mg/day) the alleviation of pain will be measured by questioning of the patients in accordance with Numeric Pain Rating Scale (NPRS).

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Secondary Outcome

Additional goal criteria for the study was the evaluation of pain after 5- and 10 days treatment with OSC according to NPRS.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   Actual
  •   2014/10/01
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

The patient is suffering from osteoporoses/osteoarthrosis

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Exclusion Criteria

There is no participation for patients who are not suffering from osteoporoses/osteoarthrosis

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Addresses

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    • Universitätsklinikum Schleswig Holstein, Hals-,Nasen-,Ohrenklinik, Kopf- und Halschirurgie
    • Mr.  PD. Dr.  Tibor  Görögh 
    • Arnold-Heller 3, Haus 27
    • 24105  Kiel
    • Germany
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    •   49 (431) 500-21701
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    •   [---]*
    •   [---]*
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    • Universitätsklinikum Schleswig-HolsteinKlinik für Orthopädie und Unfallchirurgie
    • Mr.  PD. Dr.  Sebastian  Lippross 
    • Arnold-Heller-Straße 3, Haus 18,
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein Hals-,Nasen-,Ohrenklinik, Kopf- und Halschirurgie
    • Mr.  PD. Dr.  Tibor  Görögh 
    • Arnold-Heller 3, Haus 27,
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein Hals-,Nasen-,Ohrenklinik, Kopf- und Halschirurgie
    • Mr.  PD. Dr.  Tibor  Görögh 
    • Arnold-Heller 3, Haus 27,
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Schleswig-Holstein, Hals-,Nasen-,Ohrenklinik, Kopf-und Halschirurgie
    • Arnold-Heller 3, Haus 27
    • 24105  Kiel
    • Germany
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    •   [---]*
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    • Biog
    • Mr.  PD. Dr.  Tibor  Görögh, 
    • Radward 5
    • 24223  Schwentinental
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/04/01
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Trial Publications, Results and other Documents

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