None listed
Conditions
Interventions
N.A. Type of group
N.A.
Group name:N.A. Type of group
N.A.
Sponsors
NOVARTIS BIOSCIENSES PERÚ S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Signed informed consent • Patients with advanced multiple myeloma (including osteoporotic form) and at least one osteolytic lesion or patients with breast cancer and at least one bone metastasis • Patients who have not been treated with bisphosphonates at any time prior to this study • Patients who have N-telopeptide (NTX) equal to or above the central laboratory´s mean of the normal range of post-menopausal women (67.5mmol BCE/mmol). • Normal (serum creatinine within normal limits of laboratory) or mildly impaired (serum creatinine less than 1.5 x upper limit of normal value) renal function • Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value • Performance status O, I, II (WHO classification) • Life expectancy of at least 6 months in the Investigator´s judgement • Normal corrected serum calcium level or asymptomatic mild hypercalcemia of up to 1.25 x upper limit of normal value (maximum 3 mmoL/L) • Age > 18 years
Exclusion criteria
Exclusion criteria: • Patients treated with diuretics, in whom the dose was not stable for at least 4 weeks before week O, or in whom a change in the dose is expected during the study • Patients treated with drugs of demonstrated nephrotoxic effect (see Appendix 5), in whom the dose was not stable for at least 4 weeks before week O, or in whom a change in the dose is expected during the study • Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to Visit I • Active urinary tract infection • Pregnancy and lactation • Women of childbearing potential not on a medically recognized form of contraception • Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study • Subjects participating simultaneously in studies with unapproved drugs, indications or treatment regimens. Subjects participating in studies with approved drugs in approved indications using approved treatment regimens are allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cochran-Mantel-Haenszel test statistic with modified ridit scores for non-inferíority with a non-inferiority margin of 8%. Measure:Percentage change between the baseline value and at the end of the sixth treatment cycle of the N-telopeptide / creatine (NTX / creatinine) ratio in urine. Timepoints:1, 3 and 5 cycles of the study. | — |
Countries
Argentina, Belgium, Chile, France, Germany, Italy, Russian Federation, South Africa, Spain, United States, Uruguay
Outcome results
None listed