ID

18996

Description

Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00219219

Link

https://clinicaltrials.gov/show/NCT00219219

Keywords

Versions (1)
  1. 11/29/16 11/29/16 -
Uploaded on

November 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00219219

English

Eligibility Prostate Cancer NCT00219219

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged ≥18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
histologically-proven prostate carcinoma
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
ecog performance status ≤ 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy > 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph.
Description

Secondary malignant neoplasm of bone Scan of bone | Secondary malignant neoplasm of bone Radiographic imaging procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0153690
UMLS CUI [1,2]
C0203668
UMLS CUI [2,1]
C0153690
UMLS CUI [2,2]
C1962945
patients on androgen deprivation therapy (medical therapy with lhrh analogues +
Description

Antiandrogen therapy | Luteinizing Hormone-releasing Hormone Agonist

Data type

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C1518041
antiandrogens or surgical castration) or going to start it
Description

Androgen Antagonists | Male Castration

Data type

boolean

Alias
UMLS CUI [1]
C0002842
UMLS CUI [2]
C0007347
patients with partners of childbearing potential should use a barrier method of contraception throughout the study
Description

Partner Childbearing Potential Contraception, Barrier

Data type

boolean

Alias
UMLS CUI [1,1]
C0682323
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0004764
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients without a history of metastatic disease to the bone
Description

Secondary malignant neoplasm of bone

Data type

boolean

Alias
UMLS CUI [1]
C0153690
prior treatment with bisphosphonates
Description

Diphosphonates

Data type

boolean

Alias
UMLS CUI [1]
C0012544
sres prior to visit 2
Description

Events Skeletal Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0521324
UMLS CUI [1,3]
C0439849
prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline
Description

Calcitonin | Mithramycin | gallium nitrate

Data type

boolean

Alias
UMLS CUI [1]
C0006668
UMLS CUI [2]
C0026234
UMLS CUI [3]
C0061008
corrected (adjusted for serum albumin - see appendix 5 for the calculation) serum calcium concentration < 8.0 mg/dl (2.00 mmol/l)
Description

Corrected serum calcium measurement | Serum albumin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0455288
UMLS CUI [2]
C0523465
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
Description

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Kidney Disease Serious | Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0022671
history of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
Description

Malignant Neoplasms | Skin carcinoma Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1522326
other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future
Description

Life threatening illness

Data type

boolean

Alias
UMLS CUI [1]
C3846017
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
Description

Investigational New Drugs Systemic | Investigational Medical Device Systemic | Investigational New Drugs Topical

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C2346570
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1522168
known hypersensitivity to zoledronic acid or other bisphosphonates
Description

Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0257685
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0012544
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
Description

Protocol Compliance Unwilling | Substance Use Disorders | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
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Similar models

Eligibility Prostate Cancer NCT00219219

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients aged ≥18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Prostate carcinoma
Item
histologically-proven prostate carcinoma
boolean
C0600139 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Secondary malignant neoplasm of bone Scan of bone | Secondary malignant neoplasm of bone Radiographic imaging procedure
Item
newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph.
boolean
C0153690 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C1962945 (UMLS CUI [2,2])
Antiandrogen therapy | Luteinizing Hormone-releasing Hormone Agonist
Item
patients on androgen deprivation therapy (medical therapy with lhrh analogues +
boolean
C0279492 (UMLS CUI [1])
C1518041 (UMLS CUI [2])
Androgen Antagonists | Male Castration
Item
antiandrogens or surgical castration) or going to start it
boolean
C0002842 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
Partner Childbearing Potential Contraception, Barrier
Item
patients with partners of childbearing potential should use a barrier method of contraception throughout the study
boolean
C0682323 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0004764 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of bone
Item
patients without a history of metastatic disease to the bone
boolean
C0153690 (UMLS CUI [1])
Diphosphonates
Item
prior treatment with bisphosphonates
boolean
C0012544 (UMLS CUI [1])
Events Skeletal Related
Item
sres prior to visit 2
boolean
C0441471 (UMLS CUI [1,1])
C0521324 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Calcitonin | Mithramycin | gallium nitrate
Item
prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline
boolean
C0006668 (UMLS CUI [1])
C0026234 (UMLS CUI [2])
C0061008 (UMLS CUI [3])
Corrected serum calcium measurement | Serum albumin measurement
Item
corrected (adjusted for serum albumin - see appendix 5 for the calculation) serum calcium concentration < 8.0 mg/dl (2.00 mmol/l)
boolean
C0455288 (UMLS CUI [1])
C0523465 (UMLS CUI [2])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Kidney Disease Serious | Kidney Transplantation
Item
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
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
C0022658 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0022671 (UMLS CUI [4])
Malignant Neoplasms | Skin carcinoma Treated
Item
history of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Life threatening illness
Item
other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future
boolean
C3846017 (UMLS CUI [1])
Investigational New Drugs Systemic | Investigational Medical Device Systemic | Investigational New Drugs Topical
Item
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
boolean
C0013230 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C1522168 (UMLS CUI [3,2])
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])
Protocol Compliance Unwilling | Substance Use Disorders | Informed Consent Unable
Item
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
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
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