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

This study is ongoing, but not recruiting participants.

First Received: October 14, 2005 Last Updated: September 6, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00241111

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 IV

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Assessment of the Efficacy, Tolerability and Pharmaco-Economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Further study details as provided by Novartis:

Primary Outcome Measures:

Skeletal-related event rate

Secondary Outcome Measures:

Pain scores (BPI)
Analgesic scores
Antalgic consumption
Pain evolution between 2 visits
Quality of Life - FACT-G
Performance status (ECOG)
Evaluation of urologist & patient satisfaction by questionnaire at M0 and M15
Evaluation of bone morbidity
Multiple skeletal-related event rate (Andersen Gilles analysis)
Evaluation of bone mineral density
Economic evaluation
Safety

Estimated Enrollment:	250
Study Start Date:	September 2003

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

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

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CZOL446EFR04
Study First Received:	October 14, 2005
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00241111 History of Changes
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Novartis:

Prostate
cancer
bone metastasis
zoledronic acid

Study placed in the following topic categories:

Zoledronic acid
Bone Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Hematologic Diseases
Bone Density Conservation Agents
Urogenital Neoplasms

Genital Diseases, Male
Bone Diseases
Diphosphonates
Musculoskeletal Diseases
Neoplasm Metastasis
Bone Marrow Diseases
Prostatic Neoplasms

Additional relevant MeSH terms:

Zoledronic acid
Bone Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Hematologic Diseases
Physiological Effects of Drugs
Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male
Bone Diseases

Pharmacologic Actions
Neoplastic Processes
Neoplasms
Diphosphonates
Pathologic Processes
Neoplasms by Site
Musculoskeletal Diseases
Neoplasm Metastasis
Bone Marrow Diseases
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009