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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: October 9, 2005
Last updated: March 21, 2011
Last verified: March 2011
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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Time to first skeletal complication [ Time Frame: 3 months ]
  • Bone pain [ Time Frame: 3 months ]
  • Patients´ satisfaction with treatment [ Time Frame: 3 months ]
  • Bone turnover parameters [ Time Frame: 3 months ]

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


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

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
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Please refer to this study by its identifier: NCT00237159

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

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00237159     History of Changes
Other Study ID Numbers: CZOL446EDE07
Study First Received: October 9, 2005
Last Updated: March 21, 2011

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on September 21, 2017