Effects of drug treatment with bisphosphonates (zoledronic acid) in the prevention of skeletal events in breast cancer patients with osteoporosis. Significant correlation with some biological parameters - ND

AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI0 个研究点开始时间: 2010年4月7日最近更新: 2012年4月3日

适应症

试验速览

暂无简介。

•age = or> 18 -75 aa;
•? ECOG PS 0-2;
•? diagnosis of breast cancer histologically confirmed;
•? stage of disease (stage I-III; any grading);
•? patients with malignant breast cancer with overt osteoporosis in adjuvant setting, already under loco-regional therapy (surgery + / - radiotherapy) and adjuvant chemotherapy (if indicated) at high risk of skeletal events (pathological fractures, spinal compression, radiation at skeleton and use of radioisotopes, orthopedic surgery, modification of analgesic therapy for pain OSEE);
•? osteoporosis, defined according to T score = or <-2.5 and the algorithm FRAXA;
•? positivity of breast cancer for estrogen-progestine receptors (ER + and / or PG +);
•? premenopausal patients in the adjuvant hormonal treatment for the underlying disease with tamoxifen + / - LHRH analogues;
•? postmenopausal patients adjuvant hormonal treatment for the underlying disease with aromatase inhibitors (letrozole, exemestane dell`anastrozolo except that on the basis of published scientific work is the AI which is associated with the highest risk of skeletal events determine Related to loss of bone mass);
•? written informed consent for participation in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•pregnancy and lactation;
•? hypocalcemia;
•? impaired renal function with creatinine> 1.4 mg / dl at baseline;
•? Concomitant use of nephrotoxic drugs certainly;
•? Prior treatment with zoledronic acid or in progress;
•? documented hypersensitivity to bisphosphonates;
•? presence of serious diseases osteoarticular;
•? presence of severe dental disease;
•? previous history of malignancies other than breast cancer, excluding basalioma skin and carcinoma in situ of the cervix.

发起方

AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI