ID

31536

Beschreibung

Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00426777

Link

https://clinicaltrials.gov/show/NCT00426777

Stichworte

Versionen (1)
  1. 02.09.18 02.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

2. September 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00426777

Englisch

Eligibility Prostate Cancer NCT00426777

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients over 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed diagnosis of prostate cancer without metastases.
Beschreibung

Prostate carcinoma | Neoplasm Metastasis Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
patient must have negative bone scan to rule out bone metastases.
Beschreibung

Bone scan Negative | Secondary malignant neoplasm of bone Rule out

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0203668
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C0153690
UMLS CUI [2,2]
C0332196
patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year.
Beschreibung

Indication Antiandrogen therapy | Leuprolide Acetate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0279492
UMLS CUI [2]
C0700596
eastern cooperative oncology group (ecog) score of 0 - 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
study medication must be started within 3 months of initiation of adt.
Beschreibung

Start Investigational New Drugs | Initiation Antiandrogen therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1704686
UMLS CUI [2,2]
C0279492
signed written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior adt (greater than 3 months).
Beschreibung

Antiandrogen therapy Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0205156
history of treatment with calcitriol or bisphosphonates.
Beschreibung

Calcitriol | Diphosphonates

Datentyp

boolean

Alias
UMLS CUI [1]
C0006674
UMLS CUI [2]
C0012544
suppressive doses of thyroxine within the previous year.
Beschreibung

Thyroxine Dose Suppressive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040165
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205367
concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids.
Beschreibung

Systemic Glucocorticoids Long-term

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C0443252
evidence of any of the following conditions per subject self-report or chart review:
Beschreibung

Evidence of Condition Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332120
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C1552551
current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if tsh is within normal reference range).
Beschreibung

Hyperthyroidism | Hypothyroidism | Thyroid hormone replacement therapy Stable allowed | Relationship Serum TSH level normal

Datentyp

boolean

Alias
UMLS CUI [1]
C0020550
UMLS CUI [2]
C0020676
UMLS CUI [3,1]
C2242640
UMLS CUI [3,2]
C0205360
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0580433
paget's disease, cushing's disease, hyperprolactinemia, chronic liver disease. unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization.
Beschreibung

Paget Disease | Cushing's disease | Hyperprolactinemia | Chronic liver disease | Systemic disease Unstable | Communicable Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C1368019
UMLS CUI [2]
C0221406
UMLS CUI [3]
C0020514
UMLS CUI [4]
C0341439
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0443343
UMLS CUI [6]
C0009450
UMLS CUI [7]
C1868885
UMLS CUI [8]
C0002965
UMLS CUI [9]
C0018802
UMLS CUI [10]
C0027051
major surgery or significant traumatic injury occurring within 1 month prior to randomization.
Beschreibung

Major surgery | Traumatic injury

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3263723
known hypersensitivity to leuprolide acetate or any of the components found in eligard
Beschreibung

Hypersensitivity Leuprolide Acetate | Hypersensitivity Eligard Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0700596
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1170247
UMLS CUI [2,3]
C1705248
any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
Beschreibung

Condition Study Subject Participation Status Unfavorable | Condition compromises Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00426777

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients over 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Prostate carcinoma | Neoplasm Metastasis Absent
Item
histologically confirmed diagnosis of prostate cancer without metastases.
boolean
C0600139 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Bone scan Negative | Secondary malignant neoplasm of bone Rule out
Item
patient must have negative bone scan to rule out bone metastases.
boolean
C0203668 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Indication Antiandrogen therapy | Leuprolide Acetate
Item
patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year.
boolean
C3146298 (UMLS CUI [1,1])
C0279492 (UMLS CUI [1,2])
C0700596 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) score of 0 - 2.
boolean
C1520224 (UMLS CUI [1])
Start Investigational New Drugs | Initiation Antiandrogen therapy
Item
study medication must be started within 3 months of initiation of adt.
boolean
C0439659 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1704686 (UMLS CUI [2,1])
C0279492 (UMLS CUI [2,2])
Informed Consent
Item
signed written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antiandrogen therapy Previous
Item
prior adt (greater than 3 months).
boolean
C0279492 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Calcitriol | Diphosphonates
Item
history of treatment with calcitriol or bisphosphonates.
boolean
C0006674 (UMLS CUI [1])
C0012544 (UMLS CUI [2])
Thyroxine Dose Suppressive
Item
suppressive doses of thyroxine within the previous year.
boolean
C0040165 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205367 (UMLS CUI [1,3])
Systemic Glucocorticoids Long-term
Item
concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids.
boolean
C3540777 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
Evidence of Condition Any
Item
evidence of any of the following conditions per subject self-report or chart review:
boolean
C0332120 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Hyperthyroidism | Hypothyroidism | Thyroid hormone replacement therapy Stable allowed | Relationship Serum TSH level normal
Item
current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if tsh is within normal reference range).
boolean
C0020550 (UMLS CUI [1])
C0020676 (UMLS CUI [2])
C2242640 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0580433 (UMLS CUI [4,2])
Paget Disease | Cushing's disease | Hyperprolactinemia | Chronic liver disease | Systemic disease Unstable | Communicable Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction
Item
paget's disease, cushing's disease, hyperprolactinemia, chronic liver disease. unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization.
boolean
C1368019 (UMLS CUI [1])
C0221406 (UMLS CUI [2])
C0020514 (UMLS CUI [3])
C0341439 (UMLS CUI [4])
C0442893 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0009450 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
C0002965 (UMLS CUI [8])
C0018802 (UMLS CUI [9])
C0027051 (UMLS CUI [10])
Major surgery | Traumatic injury
Item
major surgery or significant traumatic injury occurring within 1 month prior to randomization.
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
Hypersensitivity Leuprolide Acetate | Hypersensitivity Eligard Component
Item
known hypersensitivity to leuprolide acetate or any of the components found in eligard
boolean
C0020517 (UMLS CUI [1,1])
C0700596 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1170247 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Condition Study Subject Participation Status Unfavorable | Condition compromises Protocol Compliance
Item
any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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