Open-Label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

This study has been completed.

First Received: October 9, 2005 Last Updated: August 16, 2006 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00242554

Purpose

To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability

Condition	Intervention	Phase
Prostate Cancer	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, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain

Secondary Outcome Measures:

No secondary outcomes/objectives planned

Estimated Enrollment:	150
Study Start Date:	October 2002

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 18 years
Histological confirmed diagnosis of carcinoma of the prostate
Current or previous evidence of metastatic disease to the bone
Receiving currently or not, hormonal therapy
ECOG performance status of 0, 1, or 2

Exclusion Criteria:

Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less.
Corrected serum calcium concentration, adjusted for serum albumin < 8.0 mg/dl (2.00 mmol/L).
WBC<3.0x10^9, ANC < 1500/mm3, Hb < 8.0 g/dL, platelets < 75 x 10^9/L.
Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol.
Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula.

Other protocol-related inclusion / exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242554

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CZOL446EMX01
Study First Received:	October 9, 2005
Last Updated:	August 16, 2006
ClinicalTrials.gov Identifier:	NCT00242554 History of Changes
Health Authority:	Mexico: Ethics Committee

Keywords provided by Novartis:

Prostate Cancer
Bone Metastases
Zoledronic acid

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis

Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

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

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Diphosphonates
Neoplasm Metastasis
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009