A RANDOMIZED, DOUBLE-BLIND, MULTICENTRIC STUDY OF ZOLEDRONIC ACID (4 MG AND 8 MG) ADMINISTERED INTRAVENOUSLY TO PATIENTS WITH RECIDIVAL OR REFRACTORY HYPERCALCEMIA, INDUCED BY NEOPLASIA.
Not Applicable
- Conditions
- -E835 Disorders of calcium metabolismDisorders of calcium metabolismE835
- Registration Number
- PER-062-02
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
• Patients who have signed the informed consent. When the patient is not able to sign, a legal representative may do so instead.
• Patients> 18 years of age.
• Patients with a diagnosis of cancer confirmed by histology or cytology.
Exclusion Criteria
Pregnant patients. All patients with pregnancy potential must have a negative pregnancy test before the infusion of the study drug.
Patients with hyperparathyroidism, vitamin D intoxication, milk-alkaline syndrome, sarcoidosis or other granulomatous disease, adrenal insufficiency or multiple endocrine neoplasia syndromes.
Patients treated with bisphosphonates for other reasons than the TIH within 30 days prior to Visit 1.
Patients treated with calcitonin within 72 hours prior to Visit 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:A complete response is defined as the achievement of CSC concentration <2.70 mmol / L<br>Measure:Proportion of patients in the treatment group with zoledronic acid 4 mg or 8 mg who experience a complete response by Day 10.<br>Timepoints:10 day<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Time to recurrence of HIT<br>Measure:Time to recurrence of HIT<br>Timepoints:10 day<br>