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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00241111
First received: October 14, 2005
Last updated: April 7, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Prostate Cancer With Bone Metastasis
Drug: zoledronic acid
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment) [ Time Frame: at 15 months & at end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases [ Time Frame: V1, V2, V3, V5 ] [ Designated as safety issue: Yes ]
  • to assess the safety of ZOL treatment [ Time Frame: V1, V2, V3, V5 ] [ Designated as safety issue: Yes ]
  • to assess resources consumption [ Time Frame: V1, V2, V3, V5 ] [ Designated as safety issue: Yes ]
  • to assess BM [ Time Frame: V1 et V5 ] [ Designated as safety issue: Yes ]

Enrollment: 148
Study Start Date: September 2003
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Zometa Drug: zoledronic acid
Other Name: ZOl446

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Other protocol-defined inclusion / exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241111

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00241111     History of Changes
Other Study ID Numbers: CZOL446EFR04
Study First Received: October 14, 2005
Last Updated: April 7, 2010
Health Authority: France: Institutional Ethical Committee

Keywords provided by Novartis:
Prostate
cancer
bone metastasis
zoledronic acid

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
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 July 26, 2014