A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00172016
First received: September 13, 2005
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer


Condition Intervention Phase
Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated
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: A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

Resource links provided by NLM:


Further study details as provided by Novartis:

Enrollment: 43
Study Start Date: January 2004
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZOL446 (zoledronic acid) Drug: Zoledronic acid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained
  • Age > 18 years
  • Histologically confirmed diagnosis of carcinoma of the prostate
  • Current (or previous) objective evidence of metastatic disease to the bone
  • Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments
  • 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 (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
  • WBC<3.0x1'000'000'000, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 1'000'000'000/L.
  • Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
  • Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
  • Known hypersensitivity to zoledronic acid or other bisphosphonates
  • Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study

Other protocol-defined inclusion / exclusion criteria apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172016

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: NCT00172016     History of Changes
Other Study ID Numbers: CZOL446EHU01
Study First Received: September 13, 2005
Last Updated: April 27, 2012
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Novartis:
Zoledronic acid
SRE
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014