Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

NCT00241111 | Completed Phase 4

• 1 other identifier: CZOL446EFR04
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.

Conditions

Prostate Cancer With Bone Metastasis

Keywords

Prostate; cancer; bone metastasis; zoledronic acid

Outcome Measures

Primary Outcomes (1)

• to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment)

  at 15 months & at end of study

Secondary Outcomes (4)

• to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases

  V1, V2, V3, V5

• to assess the safety of ZOL treatment

  V1, V2, V3, V5

• to assess resources consumption

  V1, V2, V3, V5

• to assess BM

  V1 et V5

Study Arms (1)

Zometa

OTHER

Drug: zoledronic acid

Interventions

zoledronic acid DRUG

Also known as: ZOl446

Zometa

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years.
• Written informed consent.
• With histologically-proven prostate carcinoma.
• ECOG performance status ≤ 2
• Life expectancy \> 12 months
• Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory)
• Patients with partners of childbearing potential should use a barrier method of contraception throughout the study.

You may not qualify if:

• ECOG performans status \>3
• Prior treatment with bisphosphonates IV within the last 3 month to the study
• Renal insufficiency (serum creatinine \> 265 micromol/L or \> 3.0 mg/dL)
• Liver function tests \> 2.5 ULN
• Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol.
• History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism
• Disabling or non controlled concomitant disease likely to alter the quality of life
• Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient
• Known hypersensitivity to zoledronic acid or other bisphosphonates

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: September 1, 2003
• Primary Completion: January 1, 2006
• Last Updated: March 6, 2017

Record last verified: 2010-04