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Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00237146
First received: October 9, 2005
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.


Condition Intervention Phase
Prostate Cancer
 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: Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluate the effects of Zometa® (Zoledronic Acid) i.v in doses of 4mg for measure the following parameters of efficacy: Quality of Life, Incidence of Events related to the skeleton

Enrollment: 38
Study Start Date: November 2003
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoledronic Acid 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:

  • Age ≥18
  • histologically confirmed adenocarcinoma of the prostate.
  • Orchidectomy within the four previous weeks to enter the study.
  • bone metastasis evidenced by bone scan.
  • A hip DEXA study with a DS < 3.
  • No hormonal therapy previous to enter the study.
  • ECOG performance score of 0-2.
  • Signed written informed consent.

Exclusion Criteria:

  • Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.
  • Any kind of hormonal therapy for prostate cancer previous to enter the study.
  • Serum calcium corrected for albumin level < 8.0 mg/dl.
  • WBC < 3.0x10^3, ANC < 1500/mm3, Hemoglobin < 8.0 g/dl, platelets < 75 x 10^3/l.
  • Abnormal hepatic function evidenced by ALT and AST value >2.5 UNL
  • Subjects with any other malignant disease that can affect the bone.
  • Subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations.
  • Known hypersensibility to zoledronic acid or other bisphosphonates.
  • Subjects that in the investigator's opinion can not cooperate with the protocol.

Other protocol inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237146

Locations
Venezuela
Novartis Investigative Site
Caracas, Venezuela
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00237146     History of Changes
Other Study ID Numbers: CZOL446EVE01
Study First Received: October 9, 2005
Last Updated: February 11, 2013
Health Authority: Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:
Prostate cancer
Zoledronic acid
Bone metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
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 May 23, 2013