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

NCT ID: NCT00237159

Last Updated: 2011-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31

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.

Conditions

Prostate Cancer Patients With Bone Metastasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZOL446

Group Type: EXPERIMENTAL

Zoledronic acid

Intervention Type: DRUG

Interventions

Zoledronic acid

Intervention Type: DRUG

Other Intervention Names

ZOL446

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis Pharmaceuticals

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

CZOL446EDE07

Identifier Type: -

Identifier Source: org_study_id