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

Phase 4
18 Years
Not Enrolling
Prostate Cancer Patients With Bone Metastasis

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Trial Information

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

Inclusion 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of skeletal complications

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 2002

Completion Date:

Related Keywords:

  • Prostate Cancer Patients With Bone Metastasis
  • Prostate cancer
  • Bone metastasis
  • Skeletal related event
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases