Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237159
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : March 23, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Patients With Bone Metastasis Drug: Zoledronic acid Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 284 participants
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
Study Start Date : October 2002
Actual Primary Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: ZOL446 Drug: Zoledronic acid
Other Name: ZOL446

Primary Outcome Measures :
  1. Rate of skeletal complications [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237159

Sponsors and Collaborators
Novartis Pharmaceuticals
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00237159     History of Changes
Other Study ID Numbers: CZOL446EDE07
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011
Keywords provided by Novartis:
Prostate cancer
Bone metastasis
Skeletal related event
Additional relevant MeSH terms:
Layout table for 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