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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Bone Metastases, Zoledronic acid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    October 9, 2005
    Last Updated
    February 21, 2017
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00242554
    Brief Title
    Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Prostate Cancer, Bone Metastases, Zoledronic acid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    150 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Zoledronic acid
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    No secondary outcomes/objectives planned

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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