Prior treatment with a bisphosphonate 
Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute. 
Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L). 
Patients with clinically symptomatic brain metastases 
History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism 
Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG 
Known hypersensitivity to zoledronic acid or other bisphosphonates 
Use of other investigational drugs 30 days prior to the date of randomization 
Known history or present abuse of alcohol or drugs 
Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study 
Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. 
Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) 
Other protocol defined inclusion/exclusion criteria may apply.       
    

NCT00391690_exc_T1
Drug
bisphosphonate
NCT00391690_exc_T2
Temporal
Prior
NCT00391690_exc_T3
Measurement
renal function
NCT00391690_exc_T4
Value
Abnormal
NCT00391690_exc_T5
Measurement
calculated creatinine clearance
NCT00391690_exc_T6
Value
< 30 ml/minute
NCT00391690_exc_T7
Measurement
Corrected serum calcium concentration
NCT00391690_exc_T8
Value
< 8.0 mg/dl
NCT00391690_exc_T9
Value
2.00 mmol/L
NCT00391690_exc_T10
Value
≥ 12.0 mg/dl
NCT00391690_exc_T11
Value
3.00 mmol/L
NCT00391690_exc_T12
Scope
< 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L
NCT00391690_exc_T13
Observation
clinically symptomatic
NCT00391690_exc_T14
Condition
brain metastases
NCT00391690_exc_T15
Observation
History
NCT00391690_exc_T16
Condition
diseases with influence on bone metabolism
NCT00391690_exc_T17
Condition
Paget's disease
NCT00391690_exc_T18
Condition
primary hyperparathyroidism
NCT00391690_exc_T19
Scope
diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
NCT00391690_exc_T20
Condition
physical diseases
NCT00391690_exc_T21
Condition
psychological diseases
NCT00391690_exc_T22
Condition
ascites
NCT00391690_exc_T23
Qualifier
clinically significant
NCT00391690_exc_T24
Condition
cardiac failure
NCT00391690_exc_T25
Measurement
NYHA
NCT00391690_exc_T26
Value
III or IV
NCT00391690_exc_T27
Qualifier
clinically relevant
NCT00391690_exc_T28
Observation
pathologic findings
NCT00391690_exc_T29
Procedure
ECG
NCT00391690_exc_T30
Scope
clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG
NCT00391690_exc_T31
Scope
physical or psychological concomitant diseases
NCT00391690_exc_T32
Condition
hypersensitivity
NCT00391690_exc_T33
Drug
zoledronic acid
NCT00391690_exc_T34
Drug
other bisphosphonates
NCT00391690_exc_T35
Scope
zoledronic acid or other bisphosphonates
NCT00391690_exc_T36
Drug
other investigational drugs
NCT00391690_exc_T37
Temporal
30 days prior to the date of randomization
NCT00391690_exc_T38
Observation
history
NCT00391690_exc_T39
Temporal
present
NCT00391690_exc_T40
Scope
history or present
NCT00391690_exc_T41
Condition
abuse of alcohol
NCT00391690_exc_T42
Condition
abuse of drugs
NCT00391690_exc_T43
Scope
abuse of alcohol or drugs
NCT00391690_exc_T44
Condition
dental problems
NCT00391690_exc_T45
Temporal
Current
NCT00391690_exc_T46
Condition
infection of the teeth
NCT00391690_exc_T47
Condition
infection of the jawbone
NCT00391690_exc_T48
Scope
infection of the teeth or jawbone
NCT00391690_exc_T49
Condition
infection of the maxilla
NCT00391690_exc_T50
Condition
infection of the mandibular
NCT00391690_exc_T51
Scope
infection of the maxilla or mandibular
NCT00391690_exc_T52
Condition
dental trauma
NCT00391690_exc_T53
Condition
fixture trauma
NCT00391690_exc_T54
Temporal
current
NCT00391690_exc_T55
Temporal
prior
NCT00391690_exc_T56
Condition
osteonecrosis of the jaw (ONJ)
NCT00391690_exc_T57
Condition
exposed bone in the mouth
NCT00391690_exc_T58
Condition
slow healing after dental procedures
NCT00391690_exc_T59
Scope
osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures
NCT00391690_exc_T60
Scope
current or prior
NCT00391690_exc_T61
Scope
infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures
NCT00391690_exc_T62
Temporal
within 6 weeks
NCT00391690_exc_T63
Temporal
Recent
NCT00391690_exc_T64
Observation
planned
NCT00391690_exc_T65
Procedure
dental surgery
NCT00391690_exc_T66
Procedure
jaw surgery
NCT00391690_exc_T67
Procedure
extraction
NCT00391690_exc_T68
Procedure
implants
NCT00391690_exc_T69
Scope
extraction, implants
NCT00391690_exc_T70
Scope
dental or jaw surgery
NCT00391690_exc_T71
Scope
Recent (within 6 weeks) or planned