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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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: October 9, 2005
Last updated: February 21, 2017
Last verified: February 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
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:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00237146

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

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00237146     History of Changes
Other Study ID Numbers: CZOL446EVE01
Study First Received: October 9, 2005
Last Updated: February 21, 2017

Keywords provided by Novartis:
Prostate cancer
Zoledronic acid
Bone metastasis

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 28, 2017