Eligibility NCT00332709 Osteoporosis. Postmenopausal

ODM derived from http://clinicaltrials.gov/show/NCT00332709

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age >=18 Years
Item
Age 18 Years and older
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Compliant postmenopausal women with primary operable breast cancer after 4 to 6 years of therapy with tamoxifen (end of tamoxifen therapy within last 6 months)
Item
Compliant postmenopausal women with primary operable breast cancer after 4 to 6 years of therapy with tamoxifen (end of tamoxifen therapy within last 6 months)
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0566588 (UMLS CUI 2011AA)
289172004 (SNOMED CT 2011_0131)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0205188 (UMLS CUI 2011AA)
76234009 (SNOMED CT 2011_0131)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C0039798 (UMLS CUI 2011AA)
C0205088 (UMLS CUI 2011AA)
42796001 (SNOMED CT 2011_0131)
C0039286 (UMLS CUI 2011AA)
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
Performance status <=2 (Eastern Cooperative Oncology Group)
Item
ECOG performance status finding
boolean
C1520224 (UMLS CUI 2011AA)
424122007 (SNOMED CT 2011_0131)
Patients without severe osteoporosis at study entry
Item
Patients without severe osteoporosis at study entry
boolean
C0332288 (UMLS CUI 2011AA)
45169001 (SNOMED CT 2011_0131)
C1859443 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1705654 (UMLS CUI 2011AA)
No evidence of relapse at the time of randomization
Item
No evidence of relapse at the time of randomization
boolean
C0332125 (UMLS CUI 2011AA)
41647002 (SNOMED CT 2011_0131)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
C0040223 (UMLS CUI 2011AA)
410670007 (SNOMED CT 2011_0131)
MTHU009151 (LOINC Version 232)
C0034656 (UMLS CUI 2011AA)
Adequate function of bone marrow, kidney, and liver
Item
Adequate function of bone marrow, kidney, and liver
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0598463 (UMLS CUI 2011AA)
MTHU027728 (LOINC Version 232)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Estrogen- and progesterone-receptor status negative or unknown
Item
Estrogen- and progesterone-receptor status negative or unknown
boolean
C1516974 (UMLS CUI 2011AA)
CL415098 (UMLS CUI 2011AA)
C0279758 (UMLS CUI 2011AA)
C1514471 (UMLS CUI 2011AA)
CL415098 (UMLS CUI 2011AA)
C0279768 (UMLS CUI 2011AA)
Completion of adjuvant tamoxifen therapy more than 6 months prior to study start
Item
Completion of adjuvant tamoxifen therapy more than 6 months prior to study start
boolean
C0580352 (UMLS CUI 2011AA)
182992009 (SNOMED CT 2011_0131)
C1522673 (UMLS CUI 2011AA)
C0039286 (UMLS CUI 2011AA)
373345002 (SNOMED CT 2011_0131)
MTHU003102 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Inflammatory breast cancer
Item
Inflammatory Breast Carcinoma, Mastitis carcinomatosa
boolean
C0278601 (UMLS CUI 2011AA)
254840009 (SNOMED CT 2011_0131)
10021980 (MedDRA 14.1)
Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures
Item
Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1704330 (UMLS CUI 2011AA)
105995000 (SNOMED CT 2011_0131)
10012322 (MedDRA 14.1)
K08.9 (ICD-10-CM Version 2010)
525.9 (ICD-9-CM Version 2011)
CL425202 (UMLS CUI 2011AA)
C0877046 (UMLS CUI 2011AA)
427898007 (SNOMED CT 2011_0131)
10048762 (MedDRA 14.1)
E11594 (CTCAE 1105E)
C1400570 (UMLS CUI 2011AA)
C1301685 (UMLS CUI 2011AA)
397869004 (SNOMED CT 2011_0131)
C2363483 (UMLS CUI 2011AA)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2711248 (UMLS CUI 2011AA)
10064658 (MedDRA 14.1)
E12502 (CTCAE 1105E)
CL428750 (UMLS CUI 2011AA)
10071014 (MedDRA 14.1)
C0439834 (UMLS CUI 2011AA)
255361000 (SNOMED CT 2011_0131)
C2004454 (UMLS CUI 2011AA)
C0231290 (UMLS CUI 2011AA)
237679004, 255234002 (SNOMED CT 2011_0131)
C0011331 (UMLS CUI 2011AA)
108306002 (SNOMED CT 2011_0131)
10061813 (MedDRA 14.1)
MTHU015835 (LOINC Version 232)
Recent (within 6 weeks) or planned dental or jaw surgery
Item
Recent (within 6 weeks) or planned dental or jaw surgery
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0204324 (UMLS CUI 2011AA)
81733005 (SNOMED CT 2011_0131)
10061812 (MedDRA 14.1)
C0524861 (UMLS CUI 2011AA)
10051059 (MedDRA 14.1)
History of diseases with influence on bone metabolism such as Paget's disease and primary overactive parathyroid
Item
History of diseases with influence on bone metabolism such as Paget's disease and primary overactive parathyroid
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0814606 (UMLS CUI 2011AA)
C0596204 (UMLS CUI 2011AA)
C1368019 (UMLS CUI 2011AA)
CL414904 (UMLS CUI 2011AA)
C0443272 (UMLS CUI 2011AA)
263829006 (SNOMED CT 2011_0131)
10033288 (MedDRA 14.1)
C0030517 (UMLS CUI 2011AA)
73132005 (SNOMED CT 2011_0131)
10033942 (MedDRA 14.1)
E21.5 (ICD-10-CM Version 2010)
252.9 (ICD-9-CM Version 2011)
Prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones, Tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect the skeleton (such as calcitonin, mithramycin, or gallium nitrate)
Item
Prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones, Tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect the skeleton (such as calcitonin, mithramycin, or gallium nitrate)
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
C0348016 (UMLS CUI 2011AA)
255560000 (SNOMED CT 2011_0131)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0012544 (UMLS CUI 2011AA)
372907000 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0002845 (UMLS CUI 2011AA)
111151007 (SNOMED CT 2011_0131)
MTHU019429 (LOINC Version 232)
C1258800 (UMLS CUI 2011AA)
C0037663 (UMLS CUI 2011AA)
56234005 (SNOMED CT 2011_0131)
MTHU002890 (LOINC Version 232)
C0076660 (UMLS CUI 2011AA)
395903002 (SNOMED CT 2011_0131)
C0030520 (UMLS CUI 2011AA)
4076007 (SNOMED CT 2011_0131)
MTHU005026 (LOINC Version 232)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0037508 (UMLS CUI 2011AA)
6910009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0814606 (UMLS CUI 2011AA)
C1283922 (UMLS CUI 2011AA)
361378004 (SNOMED CT 2011_0131)
C0006668 (UMLS CUI 2011AA)
63730009 (SNOMED CT 2011_0131)
MTHU003443 (LOINC Version 232)
C0026234 (UMLS CUI 2011AA)
387101002 (SNOMED CT 2011_0131)
C0061008 (UMLS CUI 2011AA)
109092007 (SNOMED CT 2011_0131)
Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancers or in situ cancer of the cervix. Patients with previous other cancer(s) must have been disease-free for at least 5 years.
Item
Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancers or in situ cancer of the cervix. Patients with previous other cancer(s) must have been disease-free for at least 5 years.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1518422 (UMLS CUI 2011AA)
C0678222 (UMLS CUI 2011AA)
254838004 (SNOMED CT 2011_0131)
10006204 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0332288 (UMLS CUI 2011AA)
45169001 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start.
Item
Patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0012544 (UMLS CUI 2011AA)
372907000 (SNOMED CT 2011_0131)
C0457454 (UMLS CUI 2011AA)
278308006 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)

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