Trial document




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  DRKS00000721

Trial Description

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Title

Comparison of the effect of an ongoing treatment with alendronate or a drug holiday
on the fracture risk in osteoporotic patients with a bisphosphonate long term therapy

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Trial Acronym

BILANZ

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Study to evaluate the efficacy and safety of bisphosphonates in long term treatment of osteoporosis

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Brief Summary in Scientific Language


Is a continued treatment with alendronate for another two years after a preceding therapy with bisphosphonates of at least four years able to reduce the incidence of new osteoporotic fractures in patients at high fracture risk compared to a therapy-free interval?

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Organizational Data

  •   DRKS00000721
  •   2012/02/22
  •   2011/01/18
  •   yes
  •   Approved
  •   4112-11 FF, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  •   2011-000290-31 
  •   NCT01512446  (Clinical Trials.gov)
  •   4037610 
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Health Condition or Problem studied

  •   M81 -  Osteoporosis without pathological fracture
  •   M80 -  Osteoporosis with pathological fracture
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Interventions/Observational Groups

  •   Alendronate 70 mg per week for 24 months
  •   Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   [---]*
  •   Placebo
  •   Treatment
  •   Parallel
  •   IIIb
  •   Yes
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Primary Outcome

Osteoporotic fractures within 24 months, detected via patient interview and medical reporting

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Secondary Outcome


Adverse events, death

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2012/02/28
  •   7000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Postmenopausal women or men > 60 years,
DXA T-Score at lumbar spine, total hip or femur neck <-2,0 OR at least one low traumatic vertebral fracture grade 2/3 or multiple low traumatic vertebral fractures regardless of bone density Pretreatment with bisphosphonates for at least four years
Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
Signed informed consent

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Exclusion Criteria

Other pharmacological treatment of osteoporosis during the last 48 months, other bone diseases, Malabsorption syndromes, Renal insufficiency with a calculated creatinine clearance < 35 ml/min , Diseases of the esophagus, delayed esophageal clearance, Unrealisability of the intake instructions, Hypocalcemia

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Addresses

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    • Evangelisches Krankenhaus Lutherhaus gGmbH
    • Hellweg 100
    • 45276  Essen
    • Germany
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    •   0201- 8050
    •   [---]*
    •   [---]*
    •   [---]*
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    • Osteologisches Forschungszentrum Essen am Evangelischen Krankenhaus Lutherhaus gGmbH
    • Mr.  Prof. Dr. med.   Johannes   Pfeilschifter 
    • Hellweg 100
    • 45276  Essen
    • Germany
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    • Osteologisches Forschungszentrum Essen
    • Ms.  Inga  Steinebach 
    • Hellweg 100
    • 45276  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2013/03/08
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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.