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

Pain Clinical Trial

— TRAPEZE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375648
• Other study ID #: CZOL446EFR08
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2006
• Last updated: May 31, 2017
• Start date: June 2005

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Pain
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
France	Novartis Investigative Site	Monpellier

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		at 12 weeks or at 16 weeks (end of treatment)
Secondary	To measure the intensity of the pain relief of the patients with the PAR at each visit		every 3 or 4 weeks during 12 to 16 weeks
Secondary	To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5.		every 3 or 4 weeks during 12 to 16 weeks
Secondary	To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale)		every 3 or 4 weeks during 12 to 16 weeks
Secondary	To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5		every 3 or 4 weeks during 12 to 16 weeks
Secondary	To evaluate the duration of responses		at 12 weeks or at 16 weeks (end of treatment)
Secondary	To evaluate the number of skeletal related events by patient		every 3 or 4 weeks during 12 to 16 weeks
Secondary	To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5		every 3 or 4 weeks during 12 to 16 weeks
Secondary	To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal		at 12 weeks or at 16 weeks (end of treatment)

External Links

•   Results for CZOL446EFR08 from Novartis Clinical Trials website