ID

42564

Beschrijving

A Study of Actonel for the Prevention of Bone Loss; ODM derived from: https://clinicaltrials.gov/show/NCT00452439

Link

https://clinicaltrials.gov/show/NCT00452439

Trefwoorden

Versies (2)
  1. 07-10-16 07-10-16 -
  2. 02-09-21 02-09-21 -
Geüploaded op

2 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Leukemia NCT00452439

Engels

Eligibility Leukemia NCT00452439

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00452439
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age greater than or equal to 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. newly diagnosed all or ll receiving chemotherapy with augmented bfm, hyper-cvad or any variant of hyper-cvad.
Beschrijving

Acute lymphocytic leukemia | Lymphoid leukemia | Chemotherapy | Berlin-Frankfort-Munster protocol Increased | hyperCVAD protocol | hyperCVAD protocol Variant

Datatype

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023448
UMLS CUI [3]
C0392920
UMLS CUI [4,1]
C1135626
UMLS CUI [4,2]
C0205217
UMLS CUI [5]
C1742845
UMLS CUI [6,1]
C1742845
UMLS CUI [6,2]
C0205419
3. female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception.
Beschrijving

Childbearing Potential Contraceptive methods | Hysterectomy | Menstruation absent Month Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0020699
UMLS CUI [3,1]
C0497456
UMLS CUI [3,2]
C0439231
UMLS CUI [3,3]
C1265611
4. negative pregnancy test in female patients.
Beschrijving

Gender Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
5. patients must be enrolled within 6 weeks of starting induction chemotherapy.
Beschrijving

Enrollment | Induction Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C1516879
UMLS CUI [2]
C3179010
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hypocalcemia of less than 8.4 (corrected to account for the albumin level, [see appendix e for formula])
Beschrijving

Hypocalcemia | Albumin level

Datatype

boolean

Alias
UMLS CUI [1]
C0020598
UMLS CUI [2]
C0428519
2. hypersensitivity to risedronate or other bisphosphonates
Beschrijving

Hypersensitivity Risedronate | Hypersensitivity Diphosphonates

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246719
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0012544
3. inability to sit or stand upright for at least 30 minutes
Beschrijving

Unable to sit up Minute Quantity | unable to stand erect Minute Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0560836
UMLS CUI [1,2]
C0439232
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C2128578
UMLS CUI [2,2]
C0439232
UMLS CUI [2,3]
C1265611
4. bone density t-score of -2.5 s.d or less.
Beschrijving

Bone Density T score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005938
UMLS CUI [1,2]
C3854607
5. renal insufficiency (calculated creatinine clearance <30cc/min,[see appendix f for formula])
Beschrijving

Renal Insufficiency | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2711451
6. patients with a 25-hydroxyvitamin d concentration of less than 20 ng/ml and evidence of osteomalacia (low ionized calcium and high intact pth).
Beschrijving

25-Hydroxyvitamin D Measurement | Osteomalacia Evidence of | Calcium ionised decreased | Parathyroid hormone concentration above normal range

Datatype

boolean

Alias
UMLS CUI [1]
C2984945
UMLS CUI [2,1]
C0029442
UMLS CUI [2,2]
C0332120
UMLS CUI [3]
C0855662
UMLS CUI [4]
C0748089
7. concomitant use of bisphosphonates, calcitonin, anabolic steroids, or fluoride.
Beschrijving

Diphosphonates | Calcitonin | Anabolic steroids | Fluorides

Datatype

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0006668
UMLS CUI [3]
C0002845
UMLS CUI [4]
C0016327
8. corrected calcium above 10.2, due to a cause not related to leukemia/lymphoma (i.e. hyperparathyroidism, multiple myeloma).
Beschrijving

Corrected serum calcium level | Cause Related lymphoma; leukemia | Hyperparathyroidism | Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C1261202
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C1402819
UMLS CUI [3]
C0020502
UMLS CUI [4]
C0026764
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Similar models

Eligibility Leukemia NCT00452439

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00452439
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
Acute lymphocytic leukemia | Lymphoid leukemia | Chemotherapy | Berlin-Frankfort-Munster protocol Increased | hyperCVAD protocol | hyperCVAD protocol Variant
Item
2. newly diagnosed all or ll receiving chemotherapy with augmented bfm, hyper-cvad or any variant of hyper-cvad.
boolean
C0023449 (UMLS CUI [1])
C0023448 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1135626 (UMLS CUI [4,1])
C0205217 (UMLS CUI [4,2])
C1742845 (UMLS CUI [5])
C1742845 (UMLS CUI [6,1])
C0205419 (UMLS CUI [6,2])
Childbearing Potential Contraceptive methods | Hysterectomy | Menstruation absent Month Quantity
Item
3. female patients of childbearing potential (i.e. no hysterectomy, no loss of menses for 12 consecutive months), must be willing to use contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0020699 (UMLS CUI [2])
C0497456 (UMLS CUI [3,1])
C0439231 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Gender Pregnancy test negative
Item
4. negative pregnancy test in female patients.
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Enrollment | Induction Chemotherapy
Item
5. patients must be enrolled within 6 weeks of starting induction chemotherapy.
boolean
C1516879 (UMLS CUI [1])
C3179010 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypocalcemia | Albumin level
Item
1. hypocalcemia of less than 8.4 (corrected to account for the albumin level, [see appendix e for formula])
boolean
C0020598 (UMLS CUI [1])
C0428519 (UMLS CUI [2])
Hypersensitivity Risedronate | Hypersensitivity Diphosphonates
Item
2. hypersensitivity to risedronate or other bisphosphonates
boolean
C0020517 (UMLS CUI [1,1])
C0246719 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0012544 (UMLS CUI [2,2])
Unable to sit up Minute Quantity | unable to stand erect Minute Quantity
Item
3. inability to sit or stand upright for at least 30 minutes
boolean
C0560836 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2128578 (UMLS CUI [2,1])
C0439232 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Bone Density T score
Item
4. bone density t-score of -2.5 s.d or less.
boolean
C0005938 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Renal Insufficiency | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
5. renal insufficiency (calculated creatinine clearance <30cc/min,[see appendix f for formula])
boolean
C1565489 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
25-Hydroxyvitamin D Measurement | Osteomalacia Evidence of | Calcium ionised decreased | Parathyroid hormone concentration above normal range
Item
6. patients with a 25-hydroxyvitamin d concentration of less than 20 ng/ml and evidence of osteomalacia (low ionized calcium and high intact pth).
boolean
C2984945 (UMLS CUI [1])
C0029442 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0855662 (UMLS CUI [3])
C0748089 (UMLS CUI [4])
Diphosphonates | Calcitonin | Anabolic steroids | Fluorides
Item
7. concomitant use of bisphosphonates, calcitonin, anabolic steroids, or fluoride.
boolean
C0012544 (UMLS CUI [1])
C0006668 (UMLS CUI [2])
C0002845 (UMLS CUI [3])
C0016327 (UMLS CUI [4])
Corrected serum calcium level | Cause Related lymphoma; leukemia | Hyperparathyroidism | Multiple Myeloma
Item
8. corrected calcium above 10.2, due to a cause not related to leukemia/lymphoma (i.e. hyperparathyroidism, multiple myeloma).
boolean
C1261202 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C1402819 (UMLS CUI [2,3])
C0020502 (UMLS CUI [3])
C0026764 (UMLS CUI [4])
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