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Evaluation of the Efficacy and Tolerability of Zoledronic Acid in Combination With Radiotherapy in Patients With Advanced Osteolytic Bone Lesions

Phase 4
18 Years
Not Enrolling
Pain, Neoplasm Metastasis, Cancer

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Trial Information

Evaluation of the Efficacy and Tolerability of Zoledronic Acid in Combination With Radiotherapy in Patients With Advanced Osteolytic Bone Lesions

Inclusion Criteria:

- Diagnosis of at least one cancer-related bone lesion in cancer patients, confirmed by
X-ray, MRT or computer tomography

- Severity of pain ≥ 5 on item 3 of the BPI which is caused by the bone lesion(s) and
requires radiotherapy

- Adequate liver function - serum total bilirubin concentration less than 1.5 x the
upper limit of normal value

- Expected survival time ≥ 6 months

- If the patient is of child-bearing potential: negative pregnancy test at screening

- ECOG performance status of 0, 1 or 2.

- Written informed consent

Exclusion Criteria:

- Prior treatment with an oral bisphosphonate for more than 3 months or more than 3
intravenous (i.v.) bisphosphonate applications

- Bisphosphonate treatment within 6 months before study start

- Previous radiotherapy of the painful areas to be irradiated. An initiation of
radiotherapy for the target area(s) up to 3 days at maximum prior to the first
infusion is allowed.

- Skeleton-related complications (e.g., pathological fractures, orthopedic intervention
to treat or stabilize an osteolytic defect, spinal cord compression) during the last
3 weeks prior to the first infusion of trial medication.

- Initiation of a new chemotherapeutic treatment regimen during the last 2 weeks prior
to the first infusion of trial medication

- 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).

- Patients with clinically symptomatic brain metastases

- History of diseases with influence on bone metabolism such as Paget's disease and
primary hyperparathyroidism

- Pregnancy and lactation

- Women of childbearing potential not on a medically recognized form of contraception
(i.e., oral contraceptives or implants, intrauterine device [IUD], vaginal diaphragm
or sponge, or condom with spermicide)

- 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/exclusion criteria may apply.

Type of Study:


Study Design:

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

Outcome Measure:

Pain reduction

Outcome Time Frame:

weekly assessments during 48 weeks

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:

May 2002

Completion Date:

December 2008

Related Keywords:

  • Pain
  • Neoplasm Metastasis
  • Cancer
  • Pain
  • Bone metastasis
  • Analgesic consumption
  • Cancer patients
  • Cancer patients with painful bone metastasis
  • Neoplasms
  • Neoplasm Metastasis