Clareo Health | Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent
Age \> 18 years
Histologically confirmed diagnosis of carcinoma of the prostate
Objective evidence of metastatic disease to the bone as evidenced by bone scan or radiograph at any point since their diagnosis of prostate cancer
Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist or other hormonal treatments for either \< 6 months or \> 6 months
ECOG performance status of 0, 1, or 2
You may not be if
Patients who are hormone sensitive without metastatic disease to the bone
Patients who are hormone refractory typically defined as two or three consecutive increases in PSA measured at least one month apart while on hormone therapy
Patients who are not treated with LHRH agonist or other hormonal treatments
Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES
Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
Patients with abnormal renal function as evidenced by either a serum creatinine greater than 2 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less
