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

Novartis

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: Zoledronic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00375648

CZOL446EFR08

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.