Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastasis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00237159
First received: October 9, 2005
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

It is the aim of this clinical study to evaluate the skeletal-related event rate and tolerability of zoledronic acid in patients with prostate cancer patients and bone metastases.


Condition Intervention Phase
Prostate Cancer Patients With Bone Metastasis
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: Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastasis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of skeletal complications [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first skeletal complication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Bone pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Patients´ satisfaction with treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Bone turnover parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 284
Study Start Date: October 2002
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZOL446 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:

  • Signed informed consent
  • A histologically confirmed diagnosis of carcinoma of the prostate
  • Therapy with hormonal treatments (medical or surgical castration)
  • Patients must have objective evidence of metastatic disease to bone.
  • Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
  • ECOG performance status of 0, 1 or 2

Exclusion criteria:

  • Bone pain which requires strong narcotic therapy with centrally acting analgesic agents.
  • More than 3 bisphosphonate applications in patients history.
  • Previous Radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 3 months prior to Visit 2.
  • Abnormal renal function as evidenced by

A calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:

CrCl= [140-age (years)] x weight (kg) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)]

  • Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L)
  • Life expectancy < 6 months
  • Patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment
  • Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization
  • Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
  • Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Other protocol-defined inclusion and exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237159

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00237159     History of Changes
Other Study ID Numbers: CZOL446EDE07
Study First Received: October 9, 2005
Last Updated: March 21, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Prostate cancer
Bone metastasis
Skeletal related event

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
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 April 17, 2014