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

May 31, 2017 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Monpellier, France
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zoledronate
Drug: Zoledronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
at 12 weeks or at 16 weeks (end of treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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)
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
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
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)
at 12 weeks or at 16 weeks (end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 13, 2006

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446EFR08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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