None listed
Conditions
Interventions
zoledronic 4 mg Type of group
Zoledronic acid 4 mg, administered as an i.v. only 15 minutes long.
Group name:Acido zoledronic 8 mg Type of group
Zoledronic acid 8 mg, administered as an i.v. only 15 minutes long.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A complete response is defined as the achievement of CSC concentration <2.70 mmol / L Measure:Proportion of patients in the treatment group with zoledronic acid 4 mg or 8 mg who experience a complete response by Day 10. Timepoints:10 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Time to recurrence of HIT Measure:Time to recurrence of HIT Timepoints:10 day | — |
Countries
Peru
Outcome results
None listed