ID

26895

Description

Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02; ODM derived from: https://clinicaltrials.gov/show/NCT00963417

Link

https://clinicaltrials.gov/show/NCT00963417

Keywords

Versions (1)
  1. 10/28/17 10/28/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00963417

English

Eligibility Breast Cancer NCT00963417

1 forms  
Criteria
Description

Criteria

patient must be eligible and enrolled in the text-2 trial prior to enrolling in text-bone
Description

Study Subject Participation Status | Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
serial bone marrow density (bmd) measurements must be taken within the same institution
Description

Bone Mineral Density Test Series

Data type

boolean

Alias
UMLS CUI [1,1]
C0177804
UMLS CUI [1,2]
C0205549
hormone receptor positive
Description

Hormone Receptor Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1446409
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
see disease characteristics
Description

ID.5

Data type

boolean

premenopausal
Description

Premenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232969
no bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility
Description

Exclusion | Bone fracture Relationship Bone fragility

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0016658
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C1390474
no clinical or biochemical malabsorption syndrome, known vitamin d deficiency, active hyper- or hypoparathyroidism, or paget's disease
Description

Exclusion Criteria | Malabsorption Syndrome Biochemical | Vitamin D Deficiency | Hyperparathyroidism | Hypoparathyroidism | Paget's disease

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0024523
UMLS CUI [2,2]
C0205474
UMLS CUI [3]
C0042870
UMLS CUI [4]
C0020502
UMLS CUI [5]
C0020626
UMLS CUI [6]
C0029401
no uncontrolled thyroid disease, cushing disease, or other pituitary diseases
Description

Exclusion Criteria | Thyroid Disease Uncontrolled | Cushing's disease | Pituitary Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0040128
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0221406
UMLS CUI [4]
C0032002
no other bone disease (including osteomalacia or osteogenesis imperfecta)
Description

Exclusion Criteria | Bone Diseases | Osteomalacia | Osteogenesis Imperfecta

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0005940
UMLS CUI [3]
C0029442
UMLS CUI [4]
C0029434
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.12

Data type

boolean

at least 6 months since prior and no concurrent bisphosphonate therapy (or other bone therapies such as pth or strontium)
Description

Exclusion Criteria | Diphosphonates | Bone disorder therapy | Parathyroid hormone therapy | Strontium

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0012544
UMLS CUI [3]
C0872270
UMLS CUI [4]
C3839506
UMLS CUI [5]
C0038467
at least 6 months since prior glucocorticoid (> 5 mg prednisone or equivalent) for > 1 month
Description

Glucocorticoids | Prednisone Dose | Equivalent

Data type

boolean

Alias
UMLS CUI [1]
C0017710
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0178602
UMLS CUI [3]
C0205163
at least 12 months since prior anticonvulsants
Description

Anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0003286
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Similar models

Eligibility Breast Cancer NCT00963417

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Subject Participation Status | Clinical Trial Specified
Item
patient must be eligible and enrolled in the text-2 trial prior to enrolling in text-bone
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Bone Mineral Density Test Series
Item
serial bone marrow density (bmd) measurements must be taken within the same institution
boolean
C0177804 (UMLS CUI [1,1])
C0205549 (UMLS CUI [1,2])
Hormone Receptor Positive
Item
hormone receptor positive
boolean
C0019929 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ID.5
Item
see disease characteristics
boolean
Premenopausal state
Item
premenopausal
boolean
C0232969 (UMLS CUI [1])
Exclusion | Bone fracture Relationship Bone fragility
Item
no bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility
boolean
C2828389 (UMLS CUI [1])
C0016658 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1390474 (UMLS CUI [2,3])
Exclusion Criteria | Malabsorption Syndrome Biochemical | Vitamin D Deficiency | Hyperparathyroidism | Hypoparathyroidism | Paget's disease
Item
no clinical or biochemical malabsorption syndrome, known vitamin d deficiency, active hyper- or hypoparathyroidism, or paget's disease
boolean
C0680251 (UMLS CUI [1])
C0024523 (UMLS CUI [2,1])
C0205474 (UMLS CUI [2,2])
C0042870 (UMLS CUI [3])
C0020502 (UMLS CUI [4])
C0020626 (UMLS CUI [5])
C0029401 (UMLS CUI [6])
Exclusion Criteria | Thyroid Disease Uncontrolled | Cushing's disease | Pituitary Diseases
Item
no uncontrolled thyroid disease, cushing disease, or other pituitary diseases
boolean
C0680251 (UMLS CUI [1])
C0040128 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0221406 (UMLS CUI [3])
C0032002 (UMLS CUI [4])
Exclusion Criteria | Bone Diseases | Osteomalacia | Osteogenesis Imperfecta
Item
no other bone disease (including osteomalacia or osteogenesis imperfecta)
boolean
C0680251 (UMLS CUI [1])
C0005940 (UMLS CUI [2])
C0029442 (UMLS CUI [3])
C0029434 (UMLS CUI [4])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.12
Item
see disease characteristics
boolean
Exclusion Criteria | Diphosphonates | Bone disorder therapy | Parathyroid hormone therapy | Strontium
Item
at least 6 months since prior and no concurrent bisphosphonate therapy (or other bone therapies such as pth or strontium)
boolean
C0680251 (UMLS CUI [1])
C0012544 (UMLS CUI [2])
C0872270 (UMLS CUI [3])
C3839506 (UMLS CUI [4])
C0038467 (UMLS CUI [5])
Glucocorticoids | Prednisone Dose | Equivalent
Item
at least 6 months since prior glucocorticoid (> 5 mg prednisone or equivalent) for > 1 month
boolean
C0017710 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205163 (UMLS CUI [3])
Anticonvulsants
Item
at least 12 months since prior anticonvulsants
boolean
C0003286 (UMLS CUI [1])
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