Trial document




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  DRKS00009247

Trial Description

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Title

ZARA
Multicentre, non-interventional study of the efficacy and safety of zoledronic acid in skeletal related tumors (SRE) and hypercalcemia of malignancy (TIH)

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Trial Acronym

ZARA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The objective of this non-interventional study (NIS) is to collect data in both hematological diseases (e.g. multiple myeloma) as well as in solid tumors (e.g., prostate cancer, breast cancer), in order to evaluate the incidence of osteonecrosis of the jaw and kidney dysfunction. When using Zoledronic acid the impact on the reduction of bone mass as well as pain reduction should be evaluated with regard to the Karnofsky index and age.
Zoledronic acid is a compound drug which inhibits the breakdown of bone tissue. It is used in the treatment of diseases of the skeleton, such as osteoporosis and Paget's disease. Also for the prevention of bone complications in patients with cancer and for the treatment of tumor-related elevated calcium levels zoledronic acid is indicated.
Through the use of Zoledronic acid bone loss is reduced by inhibition of osteoclasts. The osteoclasts are responsible for resorption of bone.
In this prospective non-interventional study no recommendation is made for diagnosis, treatment, enforcement and ongoing study conduct. Non-interventional studies are intended to reflect the actual treatment procedure and its results. This study was reported by axios Pharma GmbH according to § 67 paragraph 6 of the AMG (German Drug Law) to the BfArM (Study No 2076) and relevant institutions defined there (GKV, PKV, KBV). A list of participating doctors and sites is thereby transmitted at regular intervals and is going to be updated. Due to legal requirements pharmaceuticals used in non-interventional trials must not be provided as pharmaceutical samples.

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Brief Summary in Scientific Language

The data obtained in pivotal studies are based on patient population estimations which are performed by statistical state of art procedures. However, due to inclusion and exclusion criteria defined by study protocols the resulting study populations may represent only a non-representative subset in terms of a real-life setting. Therefore no protocol defined inclusion or exclusion criteria will restrict the scope of additional information of this observational study. The participating practices will recommend the treatment option with zoledronic acid to all potential study patients based on official standard treatment guidelines including the SPC or the physicians’ expertise. Thus the patient population of this observational study is the result of a real-life diagnostic and therapeutic scenario. This non-interventional study (NIS) will make additional efficacy data of zoledronic acid available under said daily routine conditions, which means it will deliver additional efficacy data after marketing authorization. In particular also additional safety information will be obtained by using GCP conform documentation and reporting procedures. As a consequence the spontaneous pharmacovigilance reporting system as defined by the German Drug Law § 62 et seq. will be supported and the awareness of participating sites for adherence to said legal and ethical requirements will be sharpened.

The study design in the form of a non-interventional study (NIS) was chosen to examine the questions listed below. With the marketing authorization of zoledronic acid the SPC instrudctions of use are set regarding dose, patient clientele, treatment regimen and dose interval. There are no further obligations for use made in this NIS in order to obtain the best possible picture of practice routine. Questions under investigation are:
1. Are there previously unrecognized adverse drug reactions among zoledronic axios?
2. Was osteoporosis diagnosed before the start of treatment?
3. What is the actual risk during treatment with zoledronic acid, to acquire osteonecrosis of the jaw?
4. For which indications an increased risk for osteonecrosis of the jaw was observed?
5. Led the osteonecrosis of the jaw (ONJ)
to discontinuation or a therapy interruption?
6. Are there regular bone loss assessments carried out in order to determine bone turnovers?

Basically, the efficacy of zoledronic acid is to be observed under routine practice conditions by this non-interventional study (NIS). Secondly, the spontaneous pharmacovigilance reporting system should be supported by using the provided reporting tools and forms. Another aspect is thus also to promote attention to pharmacovigilance at site in order to fulfill the obligations according to §62 AMG ff.. in practice routine.

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Organizational Data

  •   DRKS00009247
  •   2015/08/18
  •   [---]*
  •   no
  •   Approved
  •   2015-020-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   U1111-1173-3019 
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Health Condition or Problem studied

  •   M87 -  Osteonecrosis
  •   M87.1 -  Osteonecrosis due to drugs
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Interventions/Observational Groups

  •   This non-interventional study will be conducted at hematological practices, oncological urologists and gynecologists and oncological outpatient wards of appropriate clinics based on a total study population of 800 patients. The study (NIS) is prospective, open-label und observational regarding standard of care (SOC) or routine practice respectively. Randomization is not applicable.
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Characteristics

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

Efficacy and Tolerability routine practice. Observational, non-interventional study.

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Secondary Outcome

Side effects which were not observed so far.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/08/31
  •   800
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- 18 Years old
- Informed consent was singed correctly
- Patient has advanced tumor disease which extended to the skeletal or elevated calcium serum levels as a result of malignant tumor growth
-Therapeutic decision was made independently from a possible NIS enrollment
- Patient does not participate in a clinical trial

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Exclusion Criteria

- Pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Axios Pharma Gmbh
    • Mr.  Wolfgang  Seppich 
    • Kammerichstrasse 39
    • 33647  Bielefeld
    • Germany
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    • Datafaber GbR
    • Dr  Burkard  Heckelbacher 
    • Kantstrasse 15
    • 85356  Freising
    • Germany
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    • Facharzt für Innere Medizin/Hämatologie und intern. Onkologie
    • Mr.  Dr. med.  Lars  Hahn 
    • Wiescherstr. 20
    • 44623  Herne
    • Germany
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    • Facharzt für Innere Medizin/Hämatologie und intern. Onkologie
    • Mr.  Dr. med.  Lars  Hahn 
    • Wiescherstr. 20
    • 44623  Herne
    • Germany
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Sources of Monetary or Material Support

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    • Axios Pharma Gmbh
    • Mr.  Wolfgang  Seppich 
    • Kammerichstr. 39
    • 33647  Bielefeld
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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