ID

16201

Beskrivning

Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00054418

Länk

https://clinicaltrials.gov/show/NCT00054418

Nyckelord

Versioner (1)
  1. 2016-07-05 2016-07-05 -
Uppladdad den

5 juli 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00054418

Engelsk

Eligibility Breast Cancer NCT00054418

1 Formulär  
Criteria
Beskrivning

Criteria

1. premenopausal women
Beskrivning

Premenopausal

Datatyp

boolean

Alias
UMLS CUI [1]
C0279752
≤ 6 months since last menstrual period
Beskrivning

Time Since last menstrual period

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0425932
no prior bilateral oophorectomy
Beskrivning

Bilateral oophorectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0278321
not on estrogen replacement therapy
Beskrivning

Estrogen Replacement Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0014935
if tah is performed, with at least one intact ovary, or if > 3 months since last menstrual period, then patients must have premenopausal estrogen levels ≤ 1 month of study entry
Beskrivning

Total abdominal hysterectomy | Ovary One Intact | Time Since last menstrual period | Estrogen Level Premenopausal

Datatyp

boolean

Alias
UMLS CUI [1]
C0404079
UMLS CUI [2,1]
C0029939
UMLS CUI [2,2]
C0205447
UMLS CUI [2,3]
C0205266
UMLS CUI [3,1]
C0040223
UMLS CUI [3,2]
C1711239
UMLS CUI [3,3]
C0425932
UMLS CUI [4,1]
C0202006
UMLS CUI [4,2]
C0441889
UMLS CUI [4,3]
C0279752
2. scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages i-iiib)
Beskrivning

Adjuvant Chemotherapy Breast Carcinoma Primary | Neoadjuvant Chemotherapy Breast Carcinoma Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0678222
UMLS CUI [2,4]
C0205225
3. ≥ 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status (ps) 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
2. contraindications
Beskrivning

Medical contraindication

Datatyp

boolean

Alias
UMLS CUI [1]
C1301624
1. hypercalcemia (calcium level > 1mg/dl above unl ≤ 6 months
Beskrivning

Hypercalcemia | Calcium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0020437
UMLS CUI [2]
C0201925
2. hypocalcemia (calcium level > 0.5 mg/dl below unl ≤ 6 months
Beskrivning

Hypocalcemia | Calcium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0020598
UMLS CUI [2]
C0201925
3. inability to stand or sit upright for at least 30 minutes
Beskrivning

Inability to sit or stand independently Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3554132
UMLS CUI [1,2]
C0449238
4. known swallowing disorder
Beskrivning

Deglutition Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0011168
5. bone mineral density t score of ≤ - 2.0 at the hip or lumbar spine
Beskrivning

Bone Mineral Density | T score Hip | T score Lumbar spine

Datatyp

boolean

Alias
UMLS CUI [1]
C0005938
UMLS CUI [2,1]
C3854607
UMLS CUI [2,2]
C0019552
UMLS CUI [3,1]
C3854607
UMLS CUI [3,2]
C3887615
a patient with a t score of - 2.1 is ineligible
Beskrivning

T score | Ineligibility

Datatyp

boolean

Alias
UMLS CUI [1]
C3854607
UMLS CUI [2]
C1512714
a patient with a t score of - 1.9 is eligible
Beskrivning

T score | eligible

Datatyp

boolean

Alias
UMLS CUI [1]
C3854607
UMLS CUI [2]
C1548635
6. history of vertebral compression fracture
Beskrivning

Compression fracture of vertebral column

Datatyp

boolean

Alias
UMLS CUI [1]
C0262431
exception: traumatic fracture of the coccyx would not exclude a patient from participation
Beskrivning

Fracture of coccyx Traumatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149860
UMLS CUI [1,2]
C0332663
7. corticosteroids at doses > 5 mg daily of prednison or equivalent for > 2 weeks in the past 6 months
Beskrivning

Adrenal Cortex Hormones | Prednisone | Prednisone equivalent composition

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0032952
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C3242803
8. previous treatment with bisphosphonates
Beskrivning

Diphosphonates

Datatyp

boolean

Alias
UMLS CUI [1]
C0012544
9. diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism)
Beskrivning

Disease Affecting bone metabolism | Hyperthyroidism | Hyperparathyroidism | Adrenal Gland Hyperfunction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596204
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0020502
UMLS CUI [4]
C0001622
10. history of severe renal impairment or creatinine > 2.0 mg/dl
Beskrivning

Renal Insufficiency Severe | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
11. malabsorption syndrome
Beskrivning

Malabsorption Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0024523
12. estrogen replacement therapy
Beskrivning

Estrogen Replacement Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0014935
13. oral contraceptive use
Beskrivning

Oral Contraceptives Use

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009905
UMLS CUI [1,2]
C1524063
14. prior bilateral oophorectomy
Beskrivning

bilateral oophorectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0278321
15. pregnant women
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
nursing women
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, injections, intrauterine device [iud], surgical sterilization, abstinence, etc.)
Beskrivning

Childbearing Potential Contraceptive methods Unwilling | Female Condoms | Vaginal contraceptive diaphragm | Contraceptive injection | Intrauterine Devices | Female Sterilization | Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2]
C0221829
UMLS CUI [3]
C0042241
UMLS CUI [4]
C1656586
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0015787
UMLS CUI [7]
C0036899
this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
Beskrivning

Clinical Trial Involvement with Investigational New Drug | genotoxicity Effect fetus or newborn | Mutagenic effect fetus or newborn | Teratogenic effect fetus or newborn

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0598309
UMLS CUI [2,2]
C1280500
UMLS CUI [2,3]
C1397623
UMLS CUI [3,1]
C0853802
UMLS CUI [3,2]
C1397623
UMLS CUI [4,1]
C0232910
UMLS CUI [4,2]
C1397623
16. dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment
Beskrivning

Tooth Extraction | Root Canal Therapy | Dental Prosthesis Implantation | Tooth Extraction Planned | Root Canal Therapy Planned | Dental Prosthesis Implantation Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0040440
UMLS CUI [2]
C0035849
UMLS CUI [3]
C0011370
UMLS CUI [4,1]
C0040440
UMLS CUI [4,2]
C1301732
UMLS CUI [5,1]
C0035849
UMLS CUI [5,2]
C1301732
UMLS CUI [6,1]
C0011370
UMLS CUI [6,2]
C1301732
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Similar models

Eligibility Breast Cancer NCT00054418

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Premenopausal
Item
1. premenopausal women
boolean
C0279752 (UMLS CUI [1])
Time Since last menstrual period
Item
≤ 6 months since last menstrual period
boolean
C0040223 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0425932 (UMLS CUI [1,3])
Bilateral oophorectomy
Item
no prior bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1])
Estrogen Replacement Therapy
Item
not on estrogen replacement therapy
boolean
C0014935 (UMLS CUI [1])
Total abdominal hysterectomy | Ovary One Intact | Time Since last menstrual period | Estrogen Level Premenopausal
Item
if tah is performed, with at least one intact ovary, or if > 3 months since last menstrual period, then patients must have premenopausal estrogen levels ≤ 1 month of study entry
boolean
C0404079 (UMLS CUI [1])
C0029939 (UMLS CUI [2,1])
C0205447 (UMLS CUI [2,2])
C0205266 (UMLS CUI [2,3])
C0040223 (UMLS CUI [3,1])
C1711239 (UMLS CUI [3,2])
C0425932 (UMLS CUI [3,3])
C0202006 (UMLS CUI [4,1])
C0441889 (UMLS CUI [4,2])
C0279752 (UMLS CUI [4,3])
Adjuvant Chemotherapy Breast Carcinoma Primary | Neoadjuvant Chemotherapy Breast Carcinoma Primary
Item
2. scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages i-iiib)
boolean
C0085533 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C0205225 (UMLS CUI [2,4])
Age
Item
3. ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status (ps) 0 or 1
boolean
C1520224 (UMLS CUI [1])
Medical contraindication
Item
2. contraindications
boolean
C1301624 (UMLS CUI [1])
Hypercalcemia | Calcium measurement
Item
1. hypercalcemia (calcium level > 1mg/dl above unl ≤ 6 months
boolean
C0020437 (UMLS CUI [1])
C0201925 (UMLS CUI [2])
Hypocalcemia | Calcium measurement
Item
2. hypocalcemia (calcium level > 0.5 mg/dl below unl ≤ 6 months
boolean
C0020598 (UMLS CUI [1])
C0201925 (UMLS CUI [2])
Inability to sit or stand independently Duration
Item
3. inability to stand or sit upright for at least 30 minutes
boolean
C3554132 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Deglutition Disorders
Item
4. known swallowing disorder
boolean
C0011168 (UMLS CUI [1])
Bone Mineral Density | T score Hip | T score Lumbar spine
Item
5. bone mineral density t score of ≤ - 2.0 at the hip or lumbar spine
boolean
C0005938 (UMLS CUI [1])
C3854607 (UMLS CUI [2,1])
C0019552 (UMLS CUI [2,2])
C3854607 (UMLS CUI [3,1])
C3887615 (UMLS CUI [3,2])
T score | Ineligibility
Item
a patient with a t score of - 2.1 is ineligible
boolean
C3854607 (UMLS CUI [1])
C1512714 (UMLS CUI [2])
T score | eligible
Item
a patient with a t score of - 1.9 is eligible
boolean
C3854607 (UMLS CUI [1])
C1548635 (UMLS CUI [2])
Compression fracture of vertebral column
Item
6. history of vertebral compression fracture
boolean
C0262431 (UMLS CUI [1])
Fracture of coccyx Traumatic
Item
exception: traumatic fracture of the coccyx would not exclude a patient from participation
boolean
C0149860 (UMLS CUI [1,1])
C0332663 (UMLS CUI [1,2])
Adrenal Cortex Hormones | Prednisone | Prednisone equivalent composition
Item
7. corticosteroids at doses > 5 mg daily of prednison or equivalent for > 2 weeks in the past 6 months
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
C0032952 (UMLS CUI [3,1])
C3242803 (UMLS CUI [3,2])
Diphosphonates
Item
8. previous treatment with bisphosphonates
boolean
C0012544 (UMLS CUI [1])
Disease Affecting bone metabolism | Hyperthyroidism | Hyperparathyroidism | Adrenal Gland Hyperfunction
Item
9. diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism)
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0020550 (UMLS CUI [2])
C0020502 (UMLS CUI [3])
C0001622 (UMLS CUI [4])
Renal Insufficiency Severe | Creatinine measurement, serum
Item
10. history of severe renal impairment or creatinine > 2.0 mg/dl
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Malabsorption Syndrome
Item
11. malabsorption syndrome
boolean
C0024523 (UMLS CUI [1])
Estrogen Replacement Therapy
Item
12. estrogen replacement therapy
boolean
C0014935 (UMLS CUI [1])
Oral Contraceptives Use
Item
13. oral contraceptive use
boolean
C0009905 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
bilateral oophorectomy
Item
14. prior bilateral oophorectomy
boolean
C0278321 (UMLS CUI [1])
Pregnancy
Item
15. pregnant women
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
nursing women
boolean
C0006147 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Unwilling | Female Condoms | Vaginal contraceptive diaphragm | Contraceptive injection | Intrauterine Devices | Female Sterilization | Sexual Abstinence
Item
women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, injections, intrauterine device [iud], surgical sterilization, abstinence, etc.)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0221829 (UMLS CUI [2])
C0042241 (UMLS CUI [3])
C1656586 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0015787 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
Clinical Trial Involvement with Investigational New Drug | genotoxicity Effect fetus or newborn | Mutagenic effect fetus or newborn | Teratogenic effect fetus or newborn
Item
this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
boolean
C0008976 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0598309 (UMLS CUI [2,1])
C1280500 (UMLS CUI [2,2])
C1397623 (UMLS CUI [2,3])
C0853802 (UMLS CUI [3,1])
C1397623 (UMLS CUI [3,2])
C0232910 (UMLS CUI [4,1])
C1397623 (UMLS CUI [4,2])
Tooth Extraction | Root Canal Therapy | Dental Prosthesis Implantation | Tooth Extraction Planned | Root Canal Therapy Planned | Dental Prosthesis Implantation Planned
Item
16. dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment
boolean
C0040440 (UMLS CUI [1])
C0035849 (UMLS CUI [2])
C0011370 (UMLS CUI [3])
C0040440 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0035849 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C0011370 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
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