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Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer (TRAPEZE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00375648
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : June 2, 2017
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE September 11, 2006
First Posted Date  ICMJE September 13, 2006
Last Update Posted Date June 2, 2017
Study Start Date  ICMJE June 2005
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief) [ Time Frame: at 12 weeks or at 16 weeks (end of treatment) ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
  • To measure the intensity of the pain relief of the patients with the PAR at each visit [ Time Frame: every 3 or 4 weeks during 12 to 16 weeks ]
  • To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5. [ Time Frame: every 3 or 4 weeks during 12 to 16 weeks ]
  • To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale) [ Time Frame: every 3 or 4 weeks during 12 to 16 weeks ]
  • To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5 [ Time Frame: every 3 or 4 weeks during 12 to 16 weeks ]
  • To evaluate the duration of responses [ Time Frame: at 12 weeks or at 16 weeks (end of treatment) ]
  • To evaluate the number of skeletal related events by patient [ Time Frame: every 3 or 4 weeks during 12 to 16 weeks ]
  • To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5 [ Time Frame: every 3 or 4 weeks during 12 to 16 weeks ]
  • To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal [ Time Frame: at 12 weeks or at 16 weeks (end of treatment) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Official Title  ICMJE Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Brief Summary This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE Drug: Zoledronic acid
Study Arms  ICMJE Experimental: zoledronate
Intervention: Drug: Zoledronic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2008)
61
Original Enrollment  ICMJE
 (submitted: September 11, 2006)
150
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate
  • Bone-scan documented metastases
  • Age > 18 years
  • Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion
  • Life expectancy > 3 months
  • Written informed consent

Exclusion Criteria:

  • New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks
  • Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry
  • Bisphosphonate therapy within 8 weeks before study entry
  • Abnormal renal function (serum creatinine > 2 x the upper normal limit or creatinine clearance < 30 ml/min)
  • Corrected serum calcium > 3 mmol/L or < 2 mmol/L
  • Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug
  • Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain
  • Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.)

Other protocol-defined exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00375648
Other Study ID Numbers  ICMJE CZOL446EFR08
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis Pharmaceuticals
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP