ID

25976

Description

Bone Geometry and Muscle Density Changes in Postmenopausal Women and Breast Cancer Patients Prescribed Anastrozole; ODM derived from: https://clinicaltrials.gov/show/NCT00421447

Link

https://clinicaltrials.gov/show/NCT00421447

Keywords

Versions (2)
  1. 10/2/17 10/2/17 -
  2. 10/4/17 10/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 2, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Breast Cancer NCT00421447

English

Eligibility Breast Cancer NCT00421447

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
group 1: treatment group
Description

Therapeutic procedure Group

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0441833
postmenopausal breast cancer patients (stage 1 and 2)
Description

Postmenopausal state | Breast Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C3258246
non-institutionalized
Description

Institutionalized Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0562359
UMLS CUI [1,2]
C0332197
prescribed anastrozole within the preceding 1-2 weeks
Description

Anastrozole prescribed

Data type

boolean

Alias
UMLS CUI [1,1]
C0290883
UMLS CUI [1,2]
C0278329
ambulatory
Description

Ambulatory

Data type

boolean

Alias
UMLS CUI [1]
C0439841
ability to read and comprehend study protocol and informed consent
Description

Able to read Study Protocol | Able to read Informed Consent | Comprehension Study Protocol | Comprehension Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0021430
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C2348563
UMLS CUI [4,1]
C0162340
UMLS CUI [4,2]
C0021430
group 2: control group
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
healthy, age-matched postmenopausal women
Description

Gender | Healthy | Age matched | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3898900
UMLS CUI [3,1]
C0001779
UMLS CUI [3,2]
C0150103
UMLS CUI [4]
C0232970
non-institutionalized
Description

Institutionalized Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0562359
UMLS CUI [1,2]
C0332197
ambulatory
Description

Ambulatory

Data type

boolean

Alias
UMLS CUI [1]
C0439841
ability to read and comprehend study protocol and informed consent
Description

Able to read Study Protocol | Able to read Informed Consent | Comprehension Study Protocol | Comprehension Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0021430
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C2348563
UMLS CUI [4,1]
C0162340
UMLS CUI [4,2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior tamoxifen or raloxifene therapy
Description

Tamoxifen | Raloxifene

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0244404
known congenital metabolic bone disease (e.g., osteogenesis imperfecta)
Description

Metabolic Bone Disorder Congenital | Osteogenesis Imperfecta

Data type

boolean

Alias
UMLS CUI [1,1]
C0005944
UMLS CUI [1,2]
C1744681
UMLS CUI [2]
C0029434
concomitant treatment with corticosteroids
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
patients with a history of endocrine disorders or surgical parathyroidectomy
Description

Endocrine System Diseases | Parathyroidectomy

Data type

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C0079989
patients with disorders known to affect bone metabolism including diabetes mellitus, systemic lupus erythematosus, cushing's disease, hyperparathyroidism, chronic liver disease, chronic renal failure, paget's disease
Description

Disease Affecting Bone metabolism | Diabetes Mellitus | Lupus Erythematosus, Systemic | Cushing Syndrome | Hyperparathyroidism | Chronic liver disease | Kidney Failure, Chronic | Paget's Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596204
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0024141
UMLS CUI [4]
C0010481
UMLS CUI [5]
C0020502
UMLS CUI [6]
C0341439
UMLS CUI [7]
C0022661
UMLS CUI [8]
C1368019
conditions preventing pqct measurement (e.g., unable to lie flat or still for 15 minutes)
Description

Condition Preventing Quantitative computed tomography peripheral | Lacking Able to lie quiet Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0412669
UMLS CUI [1,4]
C0205100
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0560841
UMLS CUI [2,3]
C0439654
UMLS CUI [2,4]
C0449238
geographically inaccessible for follow-up
Description

Patient unavailable Geographic Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C1517526
UMLS CUI [1,3]
C3274571
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Similar models

Eligibility Breast Cancer NCT00421447

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic procedure Group
Item
group 1: treatment group
boolean
C0087111 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Postmenopausal state | Breast Carcinoma TNM clinical staging
Item
postmenopausal breast cancer patients (stage 1 and 2)
boolean
C0232970 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Institutionalized Absent
Item
non-institutionalized
boolean
C0562359 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Anastrozole prescribed
Item
prescribed anastrozole within the preceding 1-2 weeks
boolean
C0290883 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
Ambulatory
Item
ambulatory
boolean
C0439841 (UMLS CUI [1])
Able to read Study Protocol | Able to read Informed Consent | Comprehension Study Protocol | Comprehension Informed Consent
Item
ability to read and comprehend study protocol and informed consent
boolean
C0586740 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C0162340 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
C0162340 (UMLS CUI [4,1])
C0021430 (UMLS CUI [4,2])
Control Group
Item
group 2: control group
boolean
C0009932 (UMLS CUI [1])
Gender | Healthy | Age matched | Postmenopausal state
Item
healthy, age-matched postmenopausal women
boolean
C0079399 (UMLS CUI [1])
C3898900 (UMLS CUI [2])
C0001779 (UMLS CUI [3,1])
C0150103 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
Institutionalized Absent
Item
non-institutionalized
boolean
C0562359 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Ambulatory
Item
ambulatory
boolean
C0439841 (UMLS CUI [1])
Able to read Study Protocol | Able to read Informed Consent | Comprehension Study Protocol | Comprehension Informed Consent
Item
ability to read and comprehend study protocol and informed consent
boolean
C0586740 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
C0162340 (UMLS CUI [3,1])
C2348563 (UMLS CUI [3,2])
C0162340 (UMLS CUI [4,1])
C0021430 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Tamoxifen | Raloxifene
Item
prior tamoxifen or raloxifene therapy
boolean
C0039286 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
Metabolic Bone Disorder Congenital | Osteogenesis Imperfecta
Item
known congenital metabolic bone disease (e.g., osteogenesis imperfecta)
boolean
C0005944 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
C0029434 (UMLS CUI [2])
Adrenal Cortex Hormones
Item
concomitant treatment with corticosteroids
boolean
C0001617 (UMLS CUI [1])
Endocrine System Diseases | Parathyroidectomy
Item
patients with a history of endocrine disorders or surgical parathyroidectomy
boolean
C0014130 (UMLS CUI [1])
C0079989 (UMLS CUI [2])
Disease Affecting Bone metabolism | Diabetes Mellitus | Lupus Erythematosus, Systemic | Cushing Syndrome | Hyperparathyroidism | Chronic liver disease | Kidney Failure, Chronic | Paget's Disease
Item
patients with disorders known to affect bone metabolism including diabetes mellitus, systemic lupus erythematosus, cushing's disease, hyperparathyroidism, chronic liver disease, chronic renal failure, paget's disease
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2])
C0024141 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
C0020502 (UMLS CUI [5])
C0341439 (UMLS CUI [6])
C0022661 (UMLS CUI [7])
C1368019 (UMLS CUI [8])
Condition Preventing Quantitative computed tomography peripheral | Lacking Able to lie quiet Duration
Item
conditions preventing pqct measurement (e.g., unable to lie flat or still for 15 minutes)
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0412669 (UMLS CUI [1,3])
C0205100 (UMLS CUI [1,4])
C0332268 (UMLS CUI [2,1])
C0560841 (UMLS CUI [2,2])
C0439654 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
Patient unavailable Geographic Follow-up
Item
geographically inaccessible for follow-up
boolean
C1301818 (UMLS CUI [1,1])
C1517526 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
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