ID

26611

Descripción

Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00859703

Link

https://clinicaltrials.gov/show/NCT00859703

Palabras clave

Versiones (1)
  1. 22/10/17 22/10/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de octubre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00859703

Inglés

Eligibility Breast Cancer NCT00859703

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women (more than one year since last menstrual period or removal of ovarian function by surgical or radiotherapic means)
Descripción

Postmenopausal state | Ovarian function Removal Operative Surgical Procedures | Ovarian function Removal Therapeutic radiology procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0678879
UMLS CUI [2,2]
C1883720
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0678879
UMLS CUI [3,2]
C1883720
UMLS CUI [3,3]
C1522449
operated for an invasive breast cancer (histologically proven)
Descripción

Operative Surgical Procedure Invasive carcinoma of breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0853879
surgical treatment completed and cycles of adjuvant chemotherapy (if necessary) completed
Descripción

Operative Surgical Procedures Completed | Chemotherapy cycle Adjuvant Completed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C0205197
treated with aromatase inhibitor
Descripción

Aromatase Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0593802
osteopenic (-2.5<t score<-1) without osteoporotic fracture
Descripción

Osteopenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029453
with written informed consent signed
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
with social security
Descripción

social security recipient

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0682299
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
women presenting a history of osteoporotic fracture or a t score less than -2.5 at at least one measure site
Descripción

Gender | Osteoporotic Fracture | Measurement Site Quantity T score

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0521170
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C1515974
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C3854607
women presenting clinical signs of metastases
Descripción

Gender | Sign or Symptom Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0027627
having received other hormonal treatment in the last 3 months
Descripción

Hormone Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279025
having received treatment by bisphosphonates, raloxifene, tamoxifen, parathormone, strontium ranelate, tibolone,calcitonin and corticosteroids at more than 5mg/d for 3 months in the last year
Descripción

Diphosphonates U/day | Raloxifene U/day | Tamoxifen U/day | Parathyroid Hormone U/day | strontium ranelate U/day | tibolone U/day | Calcitonin U/day | Adrenal Cortex Hormones U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0244404
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0039286
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0030520
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0936139
UMLS CUI [5,2]
C0456683
UMLS CUI [6,1]
C0076660
UMLS CUI [6,2]
C0456683
UMLS CUI [7,1]
C0006668
UMLS CUI [7,2]
C0456683
UMLS CUI [8,1]
C0001617
UMLS CUI [8,2]
C0456683
presenting a known and untreated hyperthyroid
Descripción

Hyperthyroidism untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0332155
presenting a known hyperadrenocorticism
Descripción

Adrenal Gland Hyperfunction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001622
patients treated and followed for paget's disease of bone
Descripción

Osteitis Deformans Treated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029401
UMLS CUI [1,2]
C1522326
presenting a untreated primary hyperparathyroid
Descripción

Primary Hyperparathyroidism untreated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221002
UMLS CUI [1,2]
C0332155
presenting an indication against risedronate (known hypersensibility to risedronate monosodium and/or one of its excipients, non-corrected hypocalcemia, pregnancy or breast feeding, severe renal insufficiency inferior to 30 ml/min)
Descripción

Medical contraindication Risedronate | Hypersensitivity Risedronate sodium | Hypersensitivity Risedronate sodium Excipient | Hypocalcemia uncorrected | Pregnancy | Breast Feeding | Renal Insufficiency Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0246719
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0166025
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0166025
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020598
UMLS CUI [4,2]
C4072785
UMLS CUI [5]
C0032961
UMLS CUI [6]
C0006147
UMLS CUI [7,1]
C1565489
UMLS CUI [7,2]
C0205082
patients presenting malabsorption syndrome for glucose/galactose
Descripción

glucose-galactose malabsorption

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0268186
person participating in another clinical trial concerning a medicine susceptible to influence bone mass
Descripción

Study Subject Participation Status | Pharmaceutical Preparations Affecting Bone Density

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0005938
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Similar models

Eligibility Breast Cancer NCT00859703

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state | Ovarian function Removal Operative Surgical Procedures | Ovarian function Removal Therapeutic radiology procedure
Item
postmenopausal women (more than one year since last menstrual period or removal of ovarian function by surgical or radiotherapic means)
boolean
C0232970 (UMLS CUI [1])
C0678879 (UMLS CUI [2,1])
C1883720 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0678879 (UMLS CUI [3,1])
C1883720 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
Operative Surgical Procedure Invasive carcinoma of breast
Item
operated for an invasive breast cancer (histologically proven)
boolean
C0543467 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
Operative Surgical Procedures Completed | Chemotherapy cycle Adjuvant Completed
Item
surgical treatment completed and cycles of adjuvant chemotherapy (if necessary) completed
boolean
C0543467 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1302181 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Aromatase Inhibitors
Item
treated with aromatase inhibitor
boolean
C0593802 (UMLS CUI [1])
Osteopenia
Item
osteopenic (-2.5<t score<-1) without osteoporotic fracture
boolean
C0029453 (UMLS CUI [1])
Informed Consent
Item
with written informed consent signed
boolean
C0021430 (UMLS CUI [1])
social security recipient
Item
with social security
boolean
C0682299 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender | Osteoporotic Fracture | Measurement Site Quantity T score
Item
women presenting a history of osteoporotic fracture or a t score less than -2.5 at at least one measure site
boolean
C0079399 (UMLS CUI [1])
C0521170 (UMLS CUI [2])
C0242485 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C3854607 (UMLS CUI [3,4])
Gender | Sign or Symptom Neoplasm Metastasis
Item
women presenting clinical signs of metastases
boolean
C0079399 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Hormone Therapy
Item
having received other hormonal treatment in the last 3 months
boolean
C0279025 (UMLS CUI [1])
Diphosphonates U/day | Raloxifene U/day | Tamoxifen U/day | Parathyroid Hormone U/day | strontium ranelate U/day | tibolone U/day | Calcitonin U/day | Adrenal Cortex Hormones U/day
Item
having received treatment by bisphosphonates, raloxifene, tamoxifen, parathormone, strontium ranelate, tibolone,calcitonin and corticosteroids at more than 5mg/d for 3 months in the last year
boolean
C0012544 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0244404 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0039286 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0030520 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0936139 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
C0076660 (UMLS CUI [6,1])
C0456683 (UMLS CUI [6,2])
C0006668 (UMLS CUI [7,1])
C0456683 (UMLS CUI [7,2])
C0001617 (UMLS CUI [8,1])
C0456683 (UMLS CUI [8,2])
Hyperthyroidism untreated
Item
presenting a known and untreated hyperthyroid
boolean
C0020550 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Adrenal Gland Hyperfunction
Item
presenting a known hyperadrenocorticism
boolean
C0001622 (UMLS CUI [1])
Osteitis Deformans Treated
Item
patients treated and followed for paget's disease of bone
boolean
C0029401 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
Primary Hyperparathyroidism untreated
Item
presenting a untreated primary hyperparathyroid
boolean
C0221002 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Medical contraindication Risedronate | Hypersensitivity Risedronate sodium | Hypersensitivity Risedronate sodium Excipient | Hypocalcemia uncorrected | Pregnancy | Breast Feeding | Renal Insufficiency Severe
Item
presenting an indication against risedronate (known hypersensibility to risedronate monosodium and/or one of its excipients, non-corrected hypocalcemia, pregnancy or breast feeding, severe renal insufficiency inferior to 30 ml/min)
boolean
C1301624 (UMLS CUI [1,1])
C0246719 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0166025 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0166025 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020598 (UMLS CUI [4,1])
C4072785 (UMLS CUI [4,2])
C0032961 (UMLS CUI [5])
C0006147 (UMLS CUI [6])
C1565489 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
glucose-galactose malabsorption
Item
patients presenting malabsorption syndrome for glucose/galactose
boolean
C0268186 (UMLS CUI [1])
Study Subject Participation Status | Pharmaceutical Preparations Affecting Bone Density
Item
person participating in another clinical trial concerning a medicine susceptible to influence bone mass
boolean
C2348568 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005938 (UMLS CUI [2,3])
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