ID

16190

Description

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

Link

https://clinicaltrials.gov/show/NCT00171340

Keywords

Versions (1)
  1. 7/4/16 7/4/16 -
Uploaded on

July 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Bone Loss NCT00171340

English

Eligibility Bone Loss NCT00171340

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Bone Loss NCT00171340
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage i-iiia breast cancer
Description

Breast Carcinoma | TNM clinical staging

Data type

boolean

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

Postmenopausal state

Data type

boolean

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

Operative Surgical Procedures Breast Carcinoma

Data type

boolean

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

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

Data type

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
Description

letrozole

Data type

boolean

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

ID.6

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
metastatic disease
Description

Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1]
C2939420
invasive bilateral disease
Description

Bilateral Disease Invasive

Data type

boolean

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

Spinal Fracture | Hip Fracture

Data type

boolean

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

Intravenous bisphosphonates

Data type

boolean

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

Diphosphonates Oral Discontinued

Data type

boolean

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

tibolone Use

Data type

boolean

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

Parathyroid Hormone Use

Data type

boolean

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

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
abnormal renal function
Description

Abnormal renal function

Data type

boolean

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

Disease Effect bone metabolism

Data type

boolean

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

ID.17

Data type

boolean

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Similar models

Eligibility Bone Loss NCT00171340

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Bone Loss NCT00171340
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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