ID

22515

Description

A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss; ODM derived from: https://clinicaltrials.gov/show/NCT00333229

Link

https://clinicaltrials.gov/show/NCT00333229

Keywords

Versions (2)
  1. 6/6/17 6/6/17 -
  2. 6/6/17 6/6/17 -
Uploaded on

June 6, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women NCT00333229

English

Eligibility Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women NCT00333229

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with histologically confirmed incident invasive breast cancer (t1-4) with no evidence of regional lymph node metastasis (n0) or distant metastasis (m0) and after complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
Description

Invasive carcinoma of breast TNM clinical staging | No regional lymph node metastasis | No distant metastasis | Complete excision Primary tumor | Excision of axillary lymph nodes

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0332396
UMLS CUI [3]
C0332402
UMLS CUI [4,1]
C0015250
UMLS CUI [4,2]
C0677930
UMLS CUI [5]
C0193867
hormone receptor status is negative
Description

Hormone Receptor Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1513916
patient is premenopausal (spontaneous and regular menses with premenopausal estradiol levels (>10ng/dl)
Description

Premenopausal | Menstruation Spontaneous Regular | Estradiol level Premenopausal

Data type

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2,1]
C0025344
UMLS CUI [2,2]
C0205359
UMLS CUI [2,3]
C0205272
UMLS CUI [3,1]
C1443016
UMLS CUI [3,2]
C0232969
patient receives adjuvant standard chemotherapy with approved cytotoxic chemotherapeutic drugs (e.g. ac 4-6 cycles) (prior neoadjuvant ct is allowed)
Description

Chemotherapy, Adjuvant | Cytotoxic Chemotherapy | Chemotherapy cycle Adjuvant Quantity | Neoadjuvant Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2]
C0677881
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1522673
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C0392920
bone density at study entry > -2.5 t-score
Description

Bone Density T score

Data type

boolean

Alias
UMLS CUI [1,1]
C0005938
UMLS CUI [1,2]
C3854607
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in addition to calcium and vitamin d
Description

Diphosphonates | Estrogens | Therapeutic procedure Osteoporosis | Calcium | Vitamin D

Data type

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0014939
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0029456
UMLS CUI [4]
C0006675
UMLS CUI [5]
C0042866
severe physical or psychological concomitant diseases and other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure)
Description

Comorbidity Severe | Psychological disease Severe | Comorbidity Severe Life Threatening | Myocardial Infarction | Angina Pectoris Unresponsive to Treatment | Uncontrolled hypertension Severe | Heart failure Progressive | Respiratory Insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1658764
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C2826244
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0002962
UMLS CUI [5,2]
C0205269
UMLS CUI [6,1]
C1868885
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0018801
UMLS CUI [7,2]
C0205329
UMLS CUI [8]
C0035229
known hypersensitivity to bisphosphonates
Description

Hypersensitivity Diphosphonates

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0012544
abnormal renal function
Description

Abnormal renal function

Data type

boolean

Alias
UMLS CUI [1]
C0151746
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures and recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Description

Tooth problem | Infection of tooth | infection; jaw | maxilla; infection | Mandible Communicable Disease | Dental trauma | necrosis; bone, jaw | Oral cavity Bone Exposed | Dental Procedures Healing Slow | Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implant

Data type

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]
C0009450
UMLS CUI [6]
C1301685
UMLS CUI [7]
C1390494
UMLS CUI [8,1]
C0226896
UMLS CUI [8,2]
C0262950
UMLS CUI [8,3]
C0332157
UMLS CUI [9,1]
C0011331
UMLS CUI [9,2]
C0043240
UMLS CUI [9,3]
C0439834
UMLS CUI [10]
C0204324
UMLS CUI [11]
C0407713
UMLS CUI [12]
C0040440
UMLS CUI [13]
C0011370
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Similar models

Eligibility Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women NCT00333229

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast TNM clinical staging | No regional lymph node metastasis | No distant metastasis | Complete excision Primary tumor | Excision of axillary lymph nodes
Item
female patients with histologically confirmed incident invasive breast cancer (t1-4) with no evidence of regional lymph node metastasis (n0) or distant metastasis (m0) and after complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
boolean
C0853879 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0332396 (UMLS CUI [2])
C0332402 (UMLS CUI [3])
C0015250 (UMLS CUI [4,1])
C0677930 (UMLS CUI [4,2])
C0193867 (UMLS CUI [5])
Hormone Receptor Negative
Item
hormone receptor status is negative
boolean
C0019929 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Premenopausal | Menstruation Spontaneous Regular | Estradiol level Premenopausal
Item
patient is premenopausal (spontaneous and regular menses with premenopausal estradiol levels (>10ng/dl)
boolean
C0232969 (UMLS CUI [1])
C0025344 (UMLS CUI [2,1])
C0205359 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C1443016 (UMLS CUI [3,1])
C0232969 (UMLS CUI [3,2])
Chemotherapy, Adjuvant | Cytotoxic Chemotherapy | Chemotherapy cycle Adjuvant Quantity | Neoadjuvant Chemotherapy
Item
patient receives adjuvant standard chemotherapy with approved cytotoxic chemotherapeutic drugs (e.g. ac 4-6 cycles) (prior neoadjuvant ct is allowed)
boolean
C0085533 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C1302181 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0600558 (UMLS CUI [4,1])
C0392920 (UMLS CUI [4,2])
Bone Density T score
Item
bone density at study entry > -2.5 t-score
boolean
C0005938 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diphosphonates | Estrogens | Therapeutic procedure Osteoporosis | Calcium | Vitamin D
Item
prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in addition to calcium and vitamin d
boolean
C0012544 (UMLS CUI [1])
C0014939 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0029456 (UMLS CUI [3,2])
C0006675 (UMLS CUI [4])
C0042866 (UMLS CUI [5])
Comorbidity Severe | Psychological disease Severe | Comorbidity Severe Life Threatening | Myocardial Infarction | Angina Pectoris Unresponsive to Treatment | Uncontrolled hypertension Severe | Heart failure Progressive | Respiratory Insufficiency
Item
severe physical or psychological concomitant diseases and other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure)
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1658764 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2826244 (UMLS CUI [3,3])
C0027051 (UMLS CUI [4])
C0002962 (UMLS CUI [5,1])
C0205269 (UMLS CUI [5,2])
C1868885 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0018801 (UMLS CUI [7,1])
C0205329 (UMLS CUI [7,2])
C0035229 (UMLS CUI [8])
Hypersensitivity Diphosphonates
Item
known hypersensitivity to bisphosphonates
boolean
C0020517 (UMLS CUI [1,1])
C0012544 (UMLS CUI [1,2])
Abnormal renal function
Item
abnormal renal function
boolean
C0151746 (UMLS CUI [1])
Tooth problem | Infection of tooth | infection; jaw | maxilla; infection | Mandible Communicable Disease | Dental trauma | necrosis; bone, jaw | Oral cavity Bone Exposed | Dental Procedures Healing Slow | Dental surgical procedure | Jaw Surgery | Tooth Extraction | Dental Implant
Item
current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures and recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
boolean
C0576962 (UMLS CUI [1])
C0877046 (UMLS CUI [2])
C1400570 (UMLS CUI [3])
C1400602 (UMLS CUI [4])
C0024687 (UMLS CUI [5,1])
C0009450 (UMLS CUI [5,2])
C1301685 (UMLS CUI [6])
C1390494 (UMLS CUI [7])
C0226896 (UMLS CUI [8,1])
C0262950 (UMLS CUI [8,2])
C0332157 (UMLS CUI [8,3])
C0011331 (UMLS CUI [9,1])
C0043240 (UMLS CUI [9,2])
C0439834 (UMLS CUI [9,3])
C0204324 (UMLS CUI [10])
C0407713 (UMLS CUI [11])
C0040440 (UMLS CUI [12])
C0011370 (UMLS CUI [13])
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