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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00375648
First received: September 11, 2006
Last updated: June 9, 2011
Last verified: June 2011

September 11, 2006
June 9, 2011
June 2005
July 2007   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00375648 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the duration of responses [ Time Frame: at 12 weeks or at 16 weeks (end of treatment) ] [ Designated as safety issue: Yes ]
  • To evaluate the number of skeletal related events by patient [ Time Frame: every 3 or 4 weeks during 12 to 16 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: Zoledronic acid
Experimental: zoledronate
Intervention: Drug: Zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
Not Provided
July 2007   (final data collection date for primary outcome measure)

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.

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00375648
CZOL446EFR08
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2011

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