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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00242554
First received: October 9, 2005
Last updated: April 27, 2012
Last verified: April 2012

October 9, 2005
April 27, 2012
October 2002
July 2007   (final data collection date for primary outcome measure)
To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
Not Provided
Complete list of historical versions of study NCT00242554 on ClinicalTrials.gov Archive Site
No secondary outcomes/objectives planned
Not Provided
Not Provided
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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
Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Zoledronic acid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Not Provided
July 2007   (final data collection date for primary outcome measure)

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

Male
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00242554
CZOL446EMX01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP