Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer (TRAPEZE)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00375648
First received: September 11, 2006
Last updated: June 9, 2011
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Zoledronic acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- To evaluate the duration of responses [ Time Frame: at 12 weeks or at 16 weeks (end of treatment) ] [ Designated as safety issue: Yes ]
- To evaluate the number of skeletal related events by patient [ Time Frame: every 3 or 4 weeks during 12 to 16 weeks ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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) ] [ Designated as safety issue: Yes ]
| Enrollment: | 61 |
| Study Start Date: | June 2005 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: zoledronate | Drug: Zoledronic acid |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00375648 History of Changes |
| Other Study ID Numbers: | CZOL446EFR08 |
| Study First Received: | September 11, 2006 |
| Last Updated: | June 9, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Novartis:
|
Prostate Cancer Bone metastases |
Zoledronic acid Bone metastases-related pain Prostate cancer |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Genital Diseases, Male Prostatic Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013