ID

19664

Beskrivning

Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions; ODM derived from: https://clinicaltrials.gov/show/NCT00375427

Länk

https://clinicaltrials.gov/show/NCT00375427

Nyckelord

Versioner (1)
  1. 2017-01-20 2017-01-20 -
Uppladdad den

20 januari 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer With Bone Metastasis NCT00375427

Engelsk

Eligibility Breast Cancer With Bone Metastasis NCT00375427

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients ≥ 18 years of age.
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
written informed consent given.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
histologically confirmed stage iv breast cancer with at least one bone metastasis radiologically confirmed.
Beskrivning

Breast Carcinoma TNM clinical staging | Secondary malignant neoplasm of bone Quantity Radiology

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0153690
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0043299
previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.
Beskrivning

zoledronic acid Frequency Infusion Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0257685
UMLS CUI [1,2]
C0376249
UMLS CUI [1,3]
C0574032
UMLS CUI [1,4]
C1265611
eastern cooperative oncology group (ecog) performance status ≤2 .
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy ≥ 1 year.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than 3 months since last infusion of zoledronic acid (zometa®).
Beskrivning

zoledronic acid Infusion | Zometa

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0257685
UMLS CUI [1,2]
C0574032
UMLS CUI [2]
C0939788
treatments with other bisphosphonate than zoledronic acid (zometa®) at any time prior to study entry.
Beskrivning

Diphosphonates | zoledronic acid | Zometa

Datatyp

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0257685
UMLS CUI [3]
C0939788
serum creatinine > 3 mg/dl (265 μmol/l) or calculated (cockcroft-gault formula) creatinine clearance (clcr) < 30 ml/min crcl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dl)])x 0.85
Beskrivning

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/l) or > 12 mg/dl ( 3.0 mmol/l).
Beskrivning

Corrected serum calcium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0455288
current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
Beskrivning

Tooth problem | Infection of tooth | infection; jaw | maxilla; infection | Mandible Infection | Dental trauma | Osteonecrosis of jaw | exposed bone of oral vestibule

Datatyp

boolean

Alias
UMLS CUI [1]
C0576962
UMLS CUI [2]
C0877046
UMLS CUI [3]
C1400570
UMLS CUI [4]
C1400602
UMLS CUI [5,1]
C0024687
UMLS CUI [5,2]
C3714514
UMLS CUI [6]
C1301685
UMLS CUI [7]
C2711248
UMLS CUI [8]
C2013525
recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
Beskrivning

Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0204324
UMLS CUI [2]
C0407713
UMLS CUI [3]
C0040440
UMLS CUI [4]
C0011370
pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, iud, vaginal diaphragm or sponge, or condom with spermicide).
Beskrivning

Pregnancy | Pregnancy test positive | Breast Feeding | Childbearing Potential Contraceptive methods Lacking | Sexual Abstinence | Contraceptives, Oral | Contraceptive implant | Intrauterine Devices | Contraceptive Sponge | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332268
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0009905
UMLS CUI [7]
C1657106
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0183461
UMLS CUI [10]
C0042241
UMLS CUI [11]
C0221829
UMLS CUI [12]
C0087145
history of non-compliance to medical regimens or potential unreliable behavior.
Beskrivning

Compliance behavior Limited

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
known sensitivity to study drug(s) or class of study drug(s).
Beskrivning

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Class

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0456387
patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
Beskrivning

Medical condition Severe Study Subject Participation Status Exclusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C2828389
use of any other investigational agent in the last 30 days.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Breast Cancer With Bone Metastasis NCT00375427

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients ≥ 18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed Consent
Item
written informed consent given.
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma TNM clinical staging | Secondary malignant neoplasm of bone Quantity Radiology
Item
histologically confirmed stage iv breast cancer with at least one bone metastasis radiologically confirmed.
boolean
C0678222 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0043299 (UMLS CUI [2,3])
zoledronic acid Frequency Infusion Quantity
Item
previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.
boolean
C0257685 (UMLS CUI [1,1])
C0376249 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤2 .
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 1 year.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
zoledronic acid Infusion | Zometa
Item
more than 3 months since last infusion of zoledronic acid (zometa®).
boolean
C0257685 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0939788 (UMLS CUI [2])
Diphosphonates | zoledronic acid | Zometa
Item
treatments with other bisphosphonate than zoledronic acid (zometa®) at any time prior to study entry.
boolean
C0012544 (UMLS CUI [1])
C0257685 (UMLS CUI [2])
C0939788 (UMLS CUI [3])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
serum creatinine > 3 mg/dl (265 μmol/l) or calculated (cockcroft-gault formula) creatinine clearance (clcr) < 30 ml/min crcl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dl)])x 0.85
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Corrected serum calcium measurement
Item
corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/l) or > 12 mg/dl ( 3.0 mmol/l).
boolean
C0455288 (UMLS CUI [1])
Tooth problem | Infection of tooth | infection; jaw | maxilla; infection | Mandible Infection | Dental trauma | Osteonecrosis of jaw | exposed bone of oral vestibule
Item
current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures.
boolean
C0576962 (UMLS CUI [1])
C0877046 (UMLS CUI [2])
C1400570 (UMLS CUI [3])
C1400602 (UMLS CUI [4])
C0024687 (UMLS CUI [5,1])
C3714514 (UMLS CUI [5,2])
C1301685 (UMLS CUI [6])
C2711248 (UMLS CUI [7])
C2013525 (UMLS CUI [8])
Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implantation
Item
recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
boolean
C0204324 (UMLS CUI [1])
C0407713 (UMLS CUI [2])
C0040440 (UMLS CUI [3])
C0011370 (UMLS CUI [4])
Pregnancy | Pregnancy test positive | Breast Feeding | Childbearing Potential Contraceptive methods Lacking | Sexual Abstinence | Contraceptives, Oral | Contraceptive implant | Intrauterine Devices | Contraceptive Sponge | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides
Item
pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, iud, vaginal diaphragm or sponge, or condom with spermicide).
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C0036899 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C1657106 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0183461 (UMLS CUI [9])
C0042241 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
C0087145 (UMLS CUI [12])
Compliance behavior Limited
Item
history of non-compliance to medical regimens or potential unreliable behavior.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Class
Item
known sensitivity to study drug(s) or class of study drug(s).
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
Medical condition Severe Study Subject Participation Status Exclusion
Item
patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
Investigational New Drugs
Item
use of any other investigational agent in the last 30 days.
boolean
C0013230 (UMLS CUI [1])
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