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.