ID

23474

Beschreibung

Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00485953

Link

https://clinicaltrials.gov/show/NCT00485953

Stichworte

Versionen (1)
  1. 06.07.17 06.07.17 -
Hochgeladen am

6. Juli 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Bone Loss NCT00485953

Englisch

Eligibility Bone Loss NCT00485953

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Bone Loss NCT00485953
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
elderly postmenopausal women (ages 55 and older)
Beschreibung

Postmenopausal state | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0001779
osteopenic (dxa t-score -1.0 to -2.5 sd). however, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her pcp, an osteoporotic woman may enroll in the study.
Beschreibung

Osteopenia DXA scan T score | Osteoporosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029453
UMLS CUI [1,2]
C2584897
UMLS CUI [2]
C0029456
with breast cancer on aromatase inhibitor therapy
Beschreibung

Breast Carcinoma | Aromatase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0593802
with no evidence of distant metastatic disease or osteoporosis (by bmd or clinical history)
Beschreibung

Distant metastasis Absent BMD | Osteoporosis Absent BMD

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0177804
UMLS CUI [2,1]
C0029456
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0177804
type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients
Beschreibung

Operative Surgical Procedures | Therapeutic radiology procedure | Aromatase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0593802
participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women with stage 4 breast cancer (presence of distant metastases)
Beschreibung

Breast Carcinoma TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3258246
women with normal bone density by dxa (t-score > -1.0 sd)bone density by dxa, except in the instance of a fragility fracture.
Beschreibung

Gender | Bone density Normal DXA T score

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1272809
UMLS CUI [2,2]
C0205307
UMLS CUI [2,3]
C2584897
women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated gfr <30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption.
Beschreibung

Gender | Illness Affecting Bone metabolism | Illness Affecting Mineral metabolism | Kidney Failure | eGFR | Liver Failure | Malignant Neoplasms | Breast Carcinoma Excluded | Superficial basal cell carcinoma Treated Excluded | Squamous cell carcinoma Treated Excluded | Primary Hyperparathyroidism untreated | Malabsorption

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0596204
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0678715
UMLS CUI [4]
C0035078
UMLS CUI [5]
C3811844
UMLS CUI [6]
C0085605
UMLS CUI [7]
C0006826
UMLS CUI [8,1]
C0678222
UMLS CUI [8,2]
C2828389
UMLS CUI [9,1]
C0862889
UMLS CUI [9,2]
C1522326
UMLS CUI [9,3]
C2828389
UMLS CUI [10,1]
C0007137
UMLS CUI [10,2]
C1522326
UMLS CUI [10,3]
C2828389
UMLS CUI [11,1]
C0221002
UMLS CUI [11,2]
C0332155
UMLS CUI [12]
C0024523
women being treated with oral glucocorticoid therapy >3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).
Beschreibung

Gender | Glucocorticoids Oral | Therapeutic immunosuppression | Anticonvulsants Affecting Bone metabolism | Phenobarbital | Phenytoin | Carbamazepine

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0021079
UMLS CUI [4,1]
C0003286
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0596204
UMLS CUI [5]
C0031412
UMLS CUI [6]
C0031507
UMLS CUI [7]
C0006949
those with untreated active peptic ulcer disease
Beschreibung

Peptic Ulcer untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C0332155
those with osteoporosis by bmd (t-score -2.5 sd at the spine or total hip) or a history of fragility fracture as an adult. however, as discussed above, osteoporotic women may elect to enroll in the study.
Beschreibung

Osteoporosis localized to spine BMD DXA T score | Osteoporosis Hip BMD DXA T score | History of fragility fracture Adult

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0587229
UMLS CUI [1,2]
C0177804
UMLS CUI [1,3]
C2584897
UMLS CUI [2,1]
C0029456
UMLS CUI [2,2]
C0019552
UMLS CUI [2,3]
C0177804
UMLS CUI [2,4]
C2584897
UMLS CUI [3,1]
C1272068
UMLS CUI [3,2]
C0001675
women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)
Beschreibung

Diphosphonates Oral | Calcitonin measurement | Washout Period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0201924
UMLS CUI [3]
C1710661
men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor
Beschreibung

Gender | Children

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0008059
women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study
Beschreibung

Gender | Poor dental hygiene Very | Tooth Extraction Patient need for

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0457640
UMLS CUI [2,2]
C0442824
UMLS CUI [3,1]
C0040440
UMLS CUI [3,2]
C0686904
use of fluoride for more than 1 month ever (except for dental treatment)
Beschreibung

Fluorides | Fluorides Dental care Excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0016327
UMLS CUI [2,1]
C0016327
UMLS CUI [2,2]
C0011331
UMLS CUI [2,3]
C2828389
less than 2 evaluable vertebrae
Beschreibung

Evaluation Vertebrae Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0549207
UMLS CUI [1,3]
C1265611
distant metastatic disease
Beschreibung

Distant metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C1269798
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Ähnliche Modelle

Eligibility Bone Loss NCT00485953

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Bone Loss NCT00485953
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Age
Item
elderly postmenopausal women (ages 55 and older)
boolean
C0232970 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Osteopenia DXA scan T score | Osteoporosis
Item
osteopenic (dxa t-score -1.0 to -2.5 sd). however, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her pcp, an osteoporotic woman may enroll in the study.
boolean
C0029453 (UMLS CUI [1,1])
C2584897 (UMLS CUI [1,2])
C0029456 (UMLS CUI [2])
Breast Carcinoma | Aromatase Inhibitors
Item
with breast cancer on aromatase inhibitor therapy
boolean
C0678222 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
Distant metastasis Absent BMD | Osteoporosis Absent BMD
Item
with no evidence of distant metastatic disease or osteoporosis (by bmd or clinical history)
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0177804 (UMLS CUI [1,3])
C0029456 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0177804 (UMLS CUI [2,3])
Operative Surgical Procedures | Therapeutic radiology procedure | Aromatase Inhibitors
Item
type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients
boolean
C0543467 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0593802 (UMLS CUI [3])
Informed Consent
Item
participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma TNM clinical staging
Item
women with stage 4 breast cancer (presence of distant metastases)
boolean
C0678222 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Gender | Bone density Normal DXA T score
Item
women with normal bone density by dxa (t-score > -1.0 sd)bone density by dxa, except in the instance of a fragility fracture.
boolean
C0079399 (UMLS CUI [1])
C1272809 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C2584897 (UMLS CUI [2,3])
Gender | Illness Affecting Bone metabolism | Illness Affecting Mineral metabolism | Kidney Failure | eGFR | Liver Failure | Malignant Neoplasms | Breast Carcinoma Excluded | Superficial basal cell carcinoma Treated Excluded | Squamous cell carcinoma Treated Excluded | Primary Hyperparathyroidism untreated | Malabsorption
Item
women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated gfr <30), hepatic failure, malignancy (excluding breast cancer, treated superficial basal and squamous cell carcinoma and malignancies where the diagnosis itself or its treatment would not adversely affect bone metabolism), untreated primary hyperparathyroidism, and malabsorption.
boolean
C0079399 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596204 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0678715 (UMLS CUI [3,3])
C0035078 (UMLS CUI [4])
C3811844 (UMLS CUI [5])
C0085605 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C0678222 (UMLS CUI [8,1])
C2828389 (UMLS CUI [8,2])
C0862889 (UMLS CUI [9,1])
C1522326 (UMLS CUI [9,2])
C2828389 (UMLS CUI [9,3])
C0007137 (UMLS CUI [10,1])
C1522326 (UMLS CUI [10,2])
C2828389 (UMLS CUI [10,3])
C0221002 (UMLS CUI [11,1])
C0332155 (UMLS CUI [11,2])
C0024523 (UMLS CUI [12])
Gender | Glucocorticoids Oral | Therapeutic immunosuppression | Anticonvulsants Affecting Bone metabolism | Phenobarbital | Phenytoin | Carbamazepine
Item
women being treated with oral glucocorticoid therapy >3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).
boolean
C0079399 (UMLS CUI [1])
C0017710 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0021079 (UMLS CUI [3])
C0003286 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0596204 (UMLS CUI [4,3])
C0031412 (UMLS CUI [5])
C0031507 (UMLS CUI [6])
C0006949 (UMLS CUI [7])
Peptic Ulcer untreated
Item
those with untreated active peptic ulcer disease
boolean
C0030920 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Osteoporosis localized to spine BMD DXA T score | Osteoporosis Hip BMD DXA T score | History of fragility fracture Adult
Item
those with osteoporosis by bmd (t-score -2.5 sd at the spine or total hip) or a history of fragility fracture as an adult. however, as discussed above, osteoporotic women may elect to enroll in the study.
boolean
C0587229 (UMLS CUI [1,1])
C0177804 (UMLS CUI [1,2])
C2584897 (UMLS CUI [1,3])
C0029456 (UMLS CUI [2,1])
C0019552 (UMLS CUI [2,2])
C0177804 (UMLS CUI [2,3])
C2584897 (UMLS CUI [2,4])
C1272068 (UMLS CUI [3,1])
C0001675 (UMLS CUI [3,2])
Diphosphonates Oral | Calcitonin measurement | Washout Period
Item
women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)
boolean
C0012544 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0201924 (UMLS CUI [2])
C1710661 (UMLS CUI [3])
Gender | Children
Item
men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor
boolean
C0079399 (UMLS CUI [1])
C0008059 (UMLS CUI [2])
Gender | Poor dental hygiene Very | Tooth Extraction Patient need for
Item
women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study
boolean
C0079399 (UMLS CUI [1])
C0457640 (UMLS CUI [2,1])
C0442824 (UMLS CUI [2,2])
C0040440 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Fluorides | Fluorides Dental care Excluded
Item
use of fluoride for more than 1 month ever (except for dental treatment)
boolean
C0016327 (UMLS CUI [1])
C0016327 (UMLS CUI [2,1])
C0011331 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Evaluation Vertebrae Quantity
Item
less than 2 evaluable vertebrae
boolean
C1261322 (UMLS CUI [1,1])
C0549207 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Distant metastasis
Item
distant metastatic disease
boolean
C1269798 (UMLS CUI [1])
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