Informed Consent
Item
written informed consent must be obtained
boolean
C0021430 (UMLS CUI [1])
Age
Item
age > 18 years
boolean
C0001779 (UMLS CUI [1])
Prostate carcinoma
Item
histologically confirmed diagnosis of carcinoma of the prostate
boolean
C0600139 (UMLS CUI [1])
Secondary malignant neoplasm of bone Evidence of
Item
current (or previous) objective evidence of metastatic disease to the bone
boolean
C0153690 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
First line treatment Luteinizing Hormone-releasing Hormone Agonist | Hormone Therapy Primary
Item
currently receiving 1st line hormonal therapy with lhrh agonists or other hormonal treatments
boolean
C1708063 (UMLS CUI [1,1])
C1518041 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0, 1, or 2
boolean
C1520224 (UMLS CUI [1])
Abnormal renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less
boolean
C0151746 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
Corrected serum calcium measurement | Serum albumin measurement
Item
corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/l)
boolean
C0455288 (UMLS CUI [1])
C0523465 (UMLS CUI [2])
White Blood Cell Count procedure | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement
Item
wbc<3.0x1'000'000'000, anc < 1500/mm3, hgb<8.0 g/dl, platelets < 75 x 1'000'000'000/l.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Liver Function Tests | Creatinine measurement, serum
Item
liver function tests >2.5 uln, serum creatinine >1.5 uln.
boolean
C0023901 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Disease Non-Malignant Interferes with Evaluation Primary Endpoint | Disease Non-Malignant Preventing Protocol Compliance
Item
patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
boolean
C0012634 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C2986535 (UMLS CUI [1,5])
C0012634 (UMLS CUI [2,1])
C1518371 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates
Item
known hypersensitivity to zoledronic acid or other bisphosphonates
boolean
C0020517 (UMLS CUI [1,1])
C0257685 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
Compliance behavior Limited
Item
subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Additional
Item
other protocol-defined inclusion / exclusion criteria apply.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])