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

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ClinicalTrials.gov Identifier: NCT00375648
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : June 2, 2017
Sponsor:
Information provided by:
Novartis

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Zoledronic acid Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Study Start Date : June 2005
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: zoledronate Drug: Zoledronic acid



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. To evaluate the duration of responses [ Time Frame: at 12 weeks or at 16 weeks (end of treatment) ]
  6. To evaluate the number of skeletal related events by patient [ Time Frame: every 3 or 4 weeks during 12 to 16 weeks ]
  7. 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 ]
  8. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375648


Locations
France
Novartis Investigative Site
Monpellier, France
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00375648     History of Changes
Other Study ID Numbers: CZOL446EFR08
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017

Keywords provided by Novartis:
Prostate
Cancer
Bone metastases
Zoledronic acid
Bone metastases-related pain
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs