None listed
Conditions
Interventions
Group 1 Type of group
A maximum of 6 infusions of 4 mg of zoedronate in 100 ml of solution without calcium (for example, 0.9% sodium chloride or 5% glucose), administered intravenously, for 15 minutes, every 3 or 4 weeks (depending on the antineoplastic regimen of the patient).
Group name:Group 2 Type of group
A maximum of 6 infusions of 90 mg of Aredia®, administered in 250 to 500 mL (500 mL recommended for patients with multiple myeloma) of solution without calcium (ie, 0.9% sodium chloride or 5% glucose), during 2 to 4 hours, every 3 or 4 weeks (depending on the patients antineoplastic regimen).
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Signed informed consent • Patients who have completed the 6 cycles of treatment with Aredia® or Zometa® from the central study • Performance status O, I, II (WHO Classification) • Normal corrected serum calcium level or mild hypercalcemia
Exclusion criteria
Exclusion criteria: • Patients with abnormal renal function evidenced either by a serum creatinine determination 1.5 times or more above the normal upper limit or by a calculated creatinine clearance of 60 mL / minute or less. • Pregnancy and lactation • Women of potential pregnancy age who are not under some medically recognized method of contraception • Persons who, in the investigator´s judgment, are unlikely to cooperate fully during the study • People who are participating simultaneously in studies with drugs, indications or non-approved treatment regimens. People who are participating in studies with approved drugs in approved indications are allowed using approved treatment regimens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Serum creatinine> 0.5mg / dL of the value at study admission Creatinine clearance calculated at least 30% from entry into the study Measure:Safety Timepoints:During all the visits | — |
Outcome results
None listed