ID

16190

Beskrivning

Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT00171340

Länk

https://clinicaltrials.gov/show/NCT00171340

Nyckelord

  1. 2016-07-04 2016-07-04 -
Uppladdad den

4 juli 2016

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Bone Loss NCT00171340

Eligibility Bone Loss NCT00171340

  1. StudyEvent: Eligibility
    1. Eligibility Bone Loss NCT00171340
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage i-iiia breast cancer
Beskrivning

Breast Carcinoma | TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C3258246
postmenopausal or recently postmenopausal
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
recent surgery for breast cancer
Beskrivning

Operative Surgical Procedures Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
estrogen receptor positive and/or progesterone receptor positive hormone receptor status
Beskrivning

Hormone Receptor Status Estrogen receptor positive | Hormone Receptor Status progesterone receptor positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0279754
UMLS CUI [2,1]
C0019929
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0279759
no prior treatment with letrozole
Beskrivning

letrozole

Datatyp

boolean

Alias
UMLS CUI [1]
C0246421
other protocol-defined inclusion criteria may apply.
Beskrivning

ID.6

Datatyp

boolean

Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic disease
Beskrivning

Metastatic Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C2939420
invasive bilateral disease
Beskrivning

Bilateral Disease Invasive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1511113
UMLS CUI [1,2]
C0205281
clinical or radiological evidence of existing fracture in spine or hip
Beskrivning

Spinal Fracture | Hip Fracture

Datatyp

boolean

Alias
UMLS CUI [1]
C0080179
UMLS CUI [2]
C0019557
prior treatment with iv bisphosphonates in the past 12 months
Beskrivning

Intravenous bisphosphonates

Datatyp

boolean

Alias
UMLS CUI [1]
C1955566
current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
Beskrivning

Diphosphonates Oral Discontinued

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1444662
use of tibolone within 6 months
Beskrivning

tibolone Use

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0076660
UMLS CUI [1,2]
C1524063
prior use of parathyroid hormone for more than 1 week
Beskrivning

Parathyroid Hormone Use

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030520
UMLS CUI [1,2]
C1524063
previous or concomitant malignancy
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
abnormal renal function
Beskrivning

Abnormal renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0151746
history of disease effecting bone metabolism
Beskrivning

Disease Effect bone metabolism

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1280500
UMLS CUI [1,3]
C0596204
other protocol-defined exclusion criteria may apply.
Beskrivning

ID.17

Datatyp

boolean

Similar models

Eligibility Bone Loss NCT00171340

  1. StudyEvent: Eligibility
    1. Eligibility Bone Loss NCT00171340
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | TNM clinical staging
Item
stage i-iiia breast cancer
boolean
C0678222 (UMLS CUI [1])
C3258246 (UMLS CUI [2])
Postmenopausal state
Item
postmenopausal or recently postmenopausal
boolean
C0232970 (UMLS CUI [1])
Operative Surgical Procedures Breast Carcinoma
Item
recent surgery for breast cancer
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Hormone Receptor Status Estrogen receptor positive | Hormone Receptor Status progesterone receptor positive
Item
estrogen receptor positive and/or progesterone receptor positive hormone receptor status
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0279754 (UMLS CUI [1,3])
C0019929 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0279759 (UMLS CUI [2,3])
letrozole
Item
no prior treatment with letrozole
boolean
C0246421 (UMLS CUI [1])
ID.6
Item
other protocol-defined inclusion criteria may apply.
boolean
Item Group
C0680251 (UMLS CUI)
Metastatic Neoplasm
Item
metastatic disease
boolean
C2939420 (UMLS CUI [1])
Bilateral Disease Invasive
Item
invasive bilateral disease
boolean
C1511113 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
Spinal Fracture | Hip Fracture
Item
clinical or radiological evidence of existing fracture in spine or hip
boolean
C0080179 (UMLS CUI [1])
C0019557 (UMLS CUI [2])
Intravenous bisphosphonates
Item
prior treatment with iv bisphosphonates in the past 12 months
boolean
C1955566 (UMLS CUI [1])
Diphosphonates Oral Discontinued
Item
current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
boolean
C0012544 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
tibolone Use
Item
use of tibolone within 6 months
boolean
C0076660 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Parathyroid Hormone Use
Item
prior use of parathyroid hormone for more than 1 week
boolean
C0030520 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Malignant Neoplasms
Item
previous or concomitant malignancy
boolean
C0006826 (UMLS CUI [1])
Abnormal renal function
Item
abnormal renal function
boolean
C0151746 (UMLS CUI [1])
Disease Effect bone metabolism
Item
history of disease effecting bone metabolism
boolean
C0012634 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
ID.17
Item
other protocol-defined exclusion criteria may apply.
boolean

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