Skip to main content
OpenTrials
Completed

NCT Number: NCT00375648

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site

Monpellier, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: TRAPEZE

Important dates

Study start
2005
Primary completion
2007
First posted
Sep 13, 2006
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.