Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
With
Società Italiana di Urologia (SIU)
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Patients aged ≥18 years
Written informed consent
Histologically-proven prostate carcinoma
ECOG performance status ≤ 2
Life expectancy \> 6 months
Newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph.
Patients on androgen deprivation therapy (medical therapy with LHRH analogues + antiandrogens or surgical castration) or going to start it
Patients with partners of childbearing potential should use a barrier method of contraception throughout the study
You may not be if
Patients without a history of metastatic disease to the bone
Prior treatment with bisphosphonates
SREs prior to visit 2
Prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline
Corrected (adjusted for serum albumin - see Appendix 5 for the calculation) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l)
Serum creatinine concentration \> 265 micromol/l (3.0 mg/dl) or a calculated creatinine clearance \< 30 ml/minute or serious underlying renal disease or prior renal transplantation
History of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
Other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future
Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days
Known hypersensitivity to zoledronic acid or other bisphosphonates
History of noncompliance to medical regimens and patients who are considered potentially unreliable (for example drug or alchohol abusers) or incapable of giving informed consent as judged by the investigator
Clareo Health | Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases
