PER-047-00Completed未知
OPEN MULTICENTRIC CLINICAL STUDY TO EVALUATE THE LONG-TERM SECURITY IN 4 MG OF ZOMETA (ZOLEDRONATE) IN PATIENTS WITH METASTASIC BONE INJURIES FROM BREAST CANCER OR MULTIPLE MYELOMA
OVARTIS BIOSCIENSES PERU S.A.,0 sites0 target enrollmentStarted: August 8, 2000Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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.
Investigators
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