ID

39118

Beschreibung

Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT01194440

Link

https://clinicaltrials.gov/show/NCT01194440

Stichworte

Versionen (1)
  1. 02.12.19 02.12.19 -
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See clinicaltrials.gov

Hochgeladen am

2. Dezember 2019

DOI

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Eligibility Ductal Carcinoma in Situ NCT01194440

Englisch

Eligibility Ductal Carcinoma in Situ NCT01194440

1 Formulare  
Criteria
Beschreibung

Criteria

patients with histologically proven dcis or stage i-iii invasive carcinoma of the breast that is estrogen and/or progesterone receptor positive by immunohistochemical staining who are considering aromatase inhibitor therapy; women may receive the ai on this study as initial adjuvant hormonal treatment or following tamoxifen; patients must have completed any adjuvant chemotherapy; patients may have received preoperative chemotherapy
Beschreibung

DCIS | Invasive carcinoma of breast Estrogen receptor positive TNM Breast tumor staging | Invasive carcinoma of breast Progesterone receptor positive TNM Breast tumor staging | Immunohistochemistry | Aromatase Inhibitors considering | Tamoxifen | Adjuvant Chemotherapy Completed | Preoperative Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0279754
UMLS CUI [2,3]
C0474926
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0279759
UMLS CUI [3,3]
C0474926
UMLS CUI [4]
C0021044
UMLS CUI [5,1]
C0593802
UMLS CUI [5,2]
C0750591
UMLS CUI [6]
C0039286
UMLS CUI [7,1]
C0085533
UMLS CUI [7,2]
C0205197
UMLS CUI [8]
C2347669
postmenopausal status, defined as: >= 60 years of age; or < 60 years of age and amenorrheic for >= 12 months prior to day 1 if intact uterus/ovaries; or < 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (fsh and estradiol within institutional standards for postmenopausal status); or < 60 years of age, without a uterus, and meets biochemical criteria for menopause (fsh and estradiol within institutional standards for postmenopausal status); or < 60 years of age and history of bilateral oophorectomy; or prior radiation castration with amenorrhea for at least 6 months; < 60 years of age and taking medication designed to suppress ovarian function and meets biochemical criteria for menopause (estradiol levels within institutional standards for postmenopausal status; women would have had to be taking the drug for at least 30 days prior to day 1)
Beschreibung

Postmenopausal state | Age | Amenorrhea | Uterus Intact | Both ovaries Intact | Follicle stimulating hormone measurement | Estradiol measurement | Uterus Absent | Bilateral oophorectomy | Radiation castration | Pharmaceutical Preparations Suppressing Ovarian function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0002453
UMLS CUI [4,1]
C0042149
UMLS CUI [4,2]
C0205266
UMLS CUI [5,1]
C0227898
UMLS CUI [5,2]
C0205266
UMLS CUI [6]
C0202022
UMLS CUI [7]
C0337434
UMLS CUI [8,1]
C0042149
UMLS CUI [8,2]
C0332197
UMLS CUI [9]
C0278321
UMLS CUI [10]
C0877129
UMLS CUI [11,1]
C0013227
UMLS CUI [11,2]
C1260953
UMLS CUI [11,3]
C0678879
ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form
Beschreibung

Comprehension Study Protocol | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
exclusion
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
concurrent use of hormone replacement therapy
Beschreibung

Hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0282402
concurrent use of tamoxifen; patients taking tamoxifen must discontinue the drug prior to first dose of zoledronic acid
Beschreibung

Tamoxifen | Tamoxifen To be stopped

Datentyp

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2,1]
C0039286
UMLS CUI [2,2]
C1272691
concurrent use of other selective estrogen receptor modulator (serm) such as raloxifene
Beschreibung

Selective Estrogen Receptor Modulators | Raloxifene

Datentyp

boolean

Alias
UMLS CUI [1]
C0732611
UMLS CUI [2]
C0244404
concurrent consumption of soy supplements; routine dietary consumption of soy containing foods will be permitted
Beschreibung

Consumption Soy Supplements

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0037733
UMLS CUI [1,3]
C0242295
prior use of an aromatase inhibitor in any setting
Beschreibung

Aromatase Inhibitors Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0593802
UMLS CUI [1,2]
C0205156
current bisphosphonate use (oral or intravenous); prior bisphosphonate users would be eligible as long as the use was > 1 month ago for oral bisphosphonates and/or > 12 months ago for intravenous bisphosphonates, prior to starting study treatment
Beschreibung

Diphosphonates Oral | Diphosphonates Intravenous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0012544
UMLS CUI [2,2]
C1522726
moderate to severe renal impairment (serum creatinine greater than 2 mg/dl or creatinine clearance less than 50 ml/min)
Beschreibung

Renal Insufficiency Moderate | Renal Insufficiency Severe | Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0373595
hypersensitivity to letrozole or zoledronic acid or any of its excipients
Beschreibung

Hypersensitivity Letrozole | Zoledronic acid allergy | Hypersensitivity Letrozole Excipient | Hypersensitivity Zoledronic acid Excipient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246421
UMLS CUI [2]
C4544924
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0246421
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0257685
UMLS CUI [4,3]
C0015237
concomitant treatment with oral or intravenous corticosteroids
Beschreibung

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1522726
current active dental problems including infection or 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
Beschreibung

Tooth problem | Infection of tooth | infection jaw | Maxilla infection | Lower jaw bone infection | Dental trauma | Fixture Trauma | Osteonecrosis of jaw | Exposed bone in jaw | Healing Slow | Status post Dental Procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0576962
UMLS CUI [2]
C0877046
UMLS CUI [3]
C1400570
UMLS CUI [4]
C1400602
UMLS CUI [5]
C1290708
UMLS CUI [6]
C1301685
UMLS CUI [7,1]
C3879289
UMLS CUI [7,2]
C3714660
UMLS CUI [8]
C2711248
UMLS CUI [9]
C3160827
UMLS CUI [10,1]
C0043240
UMLS CUI [10,2]
C0439834
UMLS CUI [11,1]
C0231290
UMLS CUI [11,2]
C0011331
recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
Beschreibung

Dental surgical procedure | Dental surgical procedure Planned | Jaw Surgery | Jaw Surgery Planned | Tooth Extraction | Dental Implants

Datentyp

boolean

Alias
UMLS CUI [1]
C0204324
UMLS CUI [2,1]
C0204324
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C0407713
UMLS CUI [4,1]
C0407713
UMLS CUI [4,2]
C1301732
UMLS CUI [5]
C0040440
UMLS CUI [6]
C0376511
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Ähnliche Modelle

Eligibility Ductal Carcinoma in Situ NCT01194440

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
DCIS | Invasive carcinoma of breast Estrogen receptor positive TNM Breast tumor staging | Invasive carcinoma of breast Progesterone receptor positive TNM Breast tumor staging | Immunohistochemistry | Aromatase Inhibitors considering | Tamoxifen | Adjuvant Chemotherapy Completed | Preoperative Chemotherapy
Item
patients with histologically proven dcis or stage i-iii invasive carcinoma of the breast that is estrogen and/or progesterone receptor positive by immunohistochemical staining who are considering aromatase inhibitor therapy; women may receive the ai on this study as initial adjuvant hormonal treatment or following tamoxifen; patients must have completed any adjuvant chemotherapy; patients may have received preoperative chemotherapy
boolean
C0007124 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0853879 (UMLS CUI [3,1])
C0279759 (UMLS CUI [3,2])
C0474926 (UMLS CUI [3,3])
C0021044 (UMLS CUI [4])
C0593802 (UMLS CUI [5,1])
C0750591 (UMLS CUI [5,2])
C0039286 (UMLS CUI [6])
C0085533 (UMLS CUI [7,1])
C0205197 (UMLS CUI [7,2])
C2347669 (UMLS CUI [8])
Postmenopausal state | Age | Amenorrhea | Uterus Intact | Both ovaries Intact | Follicle stimulating hormone measurement | Estradiol measurement | Uterus Absent | Bilateral oophorectomy | Radiation castration | Pharmaceutical Preparations Suppressing Ovarian function
Item
postmenopausal status, defined as: >= 60 years of age; or < 60 years of age and amenorrheic for >= 12 months prior to day 1 if intact uterus/ovaries; or < 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (fsh and estradiol within institutional standards for postmenopausal status); or < 60 years of age, without a uterus, and meets biochemical criteria for menopause (fsh and estradiol within institutional standards for postmenopausal status); or < 60 years of age and history of bilateral oophorectomy; or prior radiation castration with amenorrhea for at least 6 months; < 60 years of age and taking medication designed to suppress ovarian function and meets biochemical criteria for menopause (estradiol levels within institutional standards for postmenopausal status; women would have had to be taking the drug for at least 30 days prior to day 1)
boolean
C0232970 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0002453 (UMLS CUI [3])
C0042149 (UMLS CUI [4,1])
C0205266 (UMLS CUI [4,2])
C0227898 (UMLS CUI [5,1])
C0205266 (UMLS CUI [5,2])
C0202022 (UMLS CUI [6])
C0337434 (UMLS CUI [7])
C0042149 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0278321 (UMLS CUI [9])
C0877129 (UMLS CUI [10])
C0013227 (UMLS CUI [11,1])
C1260953 (UMLS CUI [11,2])
C0678879 (UMLS CUI [11,3])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Comprehension Study Protocol | Informed Consent
Item
patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Exclusion Criteria
Item
exclusion
boolean
C0680251 (UMLS CUI [1])
Hormone replacement therapy
Item
concurrent use of hormone replacement therapy
boolean
C0282402 (UMLS CUI [1])
Tamoxifen | Tamoxifen To be stopped
Item
concurrent use of tamoxifen; patients taking tamoxifen must discontinue the drug prior to first dose of zoledronic acid
boolean
C0039286 (UMLS CUI [1])
C0039286 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
Selective Estrogen Receptor Modulators | Raloxifene
Item
concurrent use of other selective estrogen receptor modulator (serm) such as raloxifene
boolean
C0732611 (UMLS CUI [1])
C0244404 (UMLS CUI [2])
Consumption Soy Supplements
Item
concurrent consumption of soy supplements; routine dietary consumption of soy containing foods will be permitted
boolean
C0009830 (UMLS CUI [1,1])
C0037733 (UMLS CUI [1,2])
C0242295 (UMLS CUI [1,3])
Aromatase Inhibitors Previous
Item
prior use of an aromatase inhibitor in any setting
boolean
C0593802 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Diphosphonates Oral | Diphosphonates Intravenous
Item
current bisphosphonate use (oral or intravenous); prior bisphosphonate users would be eligible as long as the use was > 1 month ago for oral bisphosphonates and/or > 12 months ago for intravenous bisphosphonates, prior to starting study treatment
boolean
C0012544 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0012544 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Renal Insufficiency Moderate | Renal Insufficiency Severe | Creatinine measurement, serum | Creatinine clearance measurement
Item
moderate to severe renal impairment (serum creatinine greater than 2 mg/dl or creatinine clearance less than 50 ml/min)
boolean
C1565489 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0201976 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
Hypersensitivity Letrozole | Zoledronic acid allergy | Hypersensitivity Letrozole Excipient | Hypersensitivity Zoledronic acid Excipient
Item
hypersensitivity to letrozole or zoledronic acid or any of its excipients
boolean
C0020517 (UMLS CUI [1,1])
C0246421 (UMLS CUI [1,2])
C4544924 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0246421 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0257685 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Intravenous
Item
concomitant treatment with oral or intravenous corticosteroids
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Tooth problem | Infection of tooth | infection jaw | Maxilla infection | Lower jaw bone infection | Dental trauma | Fixture Trauma | Osteonecrosis of jaw | Exposed bone in jaw | Healing Slow | Status post Dental Procedure
Item
current active dental problems including infection or 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
boolean
C0576962 (UMLS CUI [1])
C0877046 (UMLS CUI [2])
C1400570 (UMLS CUI [3])
C1400602 (UMLS CUI [4])
C1290708 (UMLS CUI [5])
C1301685 (UMLS CUI [6])
C3879289 (UMLS CUI [7,1])
C3714660 (UMLS CUI [7,2])
C2711248 (UMLS CUI [8])
C3160827 (UMLS CUI [9])
C0043240 (UMLS CUI [10,1])
C0439834 (UMLS CUI [10,2])
C0231290 (UMLS CUI [11,1])
C0011331 (UMLS CUI [11,2])
Dental surgical procedure | Dental surgical procedure Planned | Jaw Surgery | Jaw Surgery Planned | Tooth Extraction | Dental Implants
Item
recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
boolean
C0204324 (UMLS CUI [1])
C0204324 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0407713 (UMLS CUI [3])
C0407713 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0040440 (UMLS CUI [5])
C0376511 (UMLS CUI [6])
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