ID
42563
Beskrivning
ODM derived from http://clinicaltrials.gov/show/NCT00332709
Länk
http://clinicaltrials.gov/show/NCT00332709
Nyckelord
Versioner (4)
- 2013-12-11 2013-12-11 - Martin Dugas
- 2014-04-14 2014-04-14 - Julian Varghese
- 2021-09-02 2021-09-02 -
- 2021-09-20 2021-09-20 -
Uppladdad den
2 september 2021
DOI
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Licens
Creative Commons BY 4.0
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Eligibility NCT00332709 Osteoporosis. Postmenopausal
Eligibility
- StudyEvent: Eligibility
Beskrivning
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beskrivning
Estrogen- and progesterone-receptor status negative or unknown
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C1516974
- UMLS CUI 2011AA
- CL415098
- UMLS CUI 2011AA
- C0279758
- UMLS CUI 2011AA
- C1514471
- UMLS CUI 2011AA
- CL415098
- UMLS CUI 2011AA
- C0279768
Beskrivning
Completion of adjuvant tamoxifen therapy more than 6 months prior to study start
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0580352
- SNOMED CT 2011_0131
- 182992009
- UMLS CUI 2011AA
- C1522673
- UMLS CUI 2011AA
- C0039286
- SNOMED CT 2011_0131
- 373345002
- LOINC Version 232
- MTHU003102
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
Beskrivning
Inflammatory breast cancer
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0278601
- SNOMED CT 2011_0131
- 254840009
- MedDRA 14.1
- 10021980
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C1704330
- SNOMED CT 2011_0131
- 105995000
- MedDRA 14.1
- 10012322
- ICD-10-CM Version 2010
- K08.9
- ICD-9-CM Version 2011
- 525.9
- UMLS CUI 2011AA
- CL425202
- UMLS CUI 2011AA
- C0877046
- SNOMED CT 2011_0131
- 427898007
- MedDRA 14.1
- 10048762
- CTCAE 1105E
- E11594
- UMLS CUI 2011AA
- C1400570
- UMLS CUI 2011AA
- C1301685
- SNOMED CT 2011_0131
- 397869004
- UMLS CUI 2011AA
- C2363483
- UMLS CUI 2011AA
- C0175677
- SNOMED CT 2011_0131
- 417746004
- MedDRA 14.1
- 10022116
- ICD-10-CM Version 2010
- T14.9
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
- UMLS CUI 2011AA
- C1401381
- MedDRA 14.1
- 10064658
- CTCAE 1105E
- E12502
- UMLS CUI 2011AA
- CL428750
- MedDRA 14.1
- 10071014
- UMLS CUI 2011AA
- C0439834
- SNOMED CT 2011_0131
- 255361000
- UMLS CUI 2011AA
- C2004454
- UMLS CUI 2011AA
- C0231290
- SNOMED CT 2011_0131
- 237679004, 255234002
- UMLS CUI 2011AA
- C0011331
- SNOMED CT 2011_0131
- 108306002
- MedDRA 14.1
- 10061813
- LOINC Version 232
- MTHU015835
Beskrivning
Recent (within 6 weeks) or planned dental or jaw surgery
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0332185
- SNOMED CT 2011_0131
- 6493001
- UMLS CUI 2011AA
- C1301732
- SNOMED CT 2011_0131
- 397943006
- UMLS CUI 2011AA
- C0204324
- SNOMED CT 2011_0131
- 81733005
- MedDRA 14.1
- 10061812
- UMLS CUI 2011AA
- C0524861
- MedDRA 14.1
- 10051059
Beskrivning
History of diseases with influence on bone metabolism such as Paget's disease and primary overactive parathyroid
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0814606
- UMLS CUI 2011AA
- C0596204
- UMLS CUI 2011AA
- C1368019
- UMLS CUI 2011AA
- CL414904
- UMLS CUI 2011AA
- C0443272
- SNOMED CT 2011_0131
- 263829006
- MedDRA 14.1
- 10033288
- UMLS CUI 2011AA
- C0030517
- SNOMED CT 2011_0131
- 73132005
- MedDRA 14.1
- 10033942
- ICD-10-CM Version 2010
- E21.5
- ICD-9-CM Version 2011
- 252.9
Beskrivning
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)
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- CL415222
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0392920
- SNOMED CT 2011_0131
- 150415003
- UMLS CUI 2011AA
- C0348016
- SNOMED CT 2011_0131
- 255560000
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- C0012544
- SNOMED CT 2011_0131
- 372907000
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
- UMLS CUI 2011AA
- C0002845
- SNOMED CT 2011_0131
- 111151007
- LOINC Version 232
- MTHU019429
- UMLS CUI 2011AA
- C1258800
- UMLS CUI 2011AA
- C0037663
- SNOMED CT 2011_0131
- 56234005
- LOINC Version 232
- MTHU002890
- UMLS CUI 2011AA
- C0076660
- SNOMED CT 2011_0131
- 395903002
- UMLS CUI 2011AA
- C0030520
- SNOMED CT 2011_0131
- 4076007
- LOINC Version 232
- MTHU005026
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C0037508
- SNOMED CT 2011_0131
- 6910009
- UMLS CUI 2011AA
- C0013227
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C0814606
- UMLS CUI 2011AA
- C1283922
- SNOMED CT 2011_0131
- 361378004
- UMLS CUI 2011AA
- C0006668
- SNOMED CT 2011_0131
- 63730009
- LOINC Version 232
- MTHU003443
- UMLS CUI 2011AA
- C0026234
- SNOMED CT 2011_0131
- 387101002
- UMLS CUI 2011AA
- C0061008
- SNOMED CT 2011_0131
- 109092007
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- CL415222
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C0678222
- SNOMED CT 2011_0131
- 254838004
- MedDRA 14.1
- 10006204
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0205411
- SNOMED CT 2011_0131
- 88323005
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
- UMLS CUI 2011AA
- C0851140
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
- UMLS CUI 2011AA
- C0332288
- SNOMED CT 2011_0131
- 45169001
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
Beskrivning
Patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start.
Datatyp
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1527415
- SNOMED CT 2011_0131
- 26643006
- HL7 V3 2006_05
- _OralRoute
- UMLS CUI 2011AA
- C0012544
- SNOMED CT 2011_0131
- 372907000
- UMLS CUI 2011AA
- C0457454
- SNOMED CT 2011_0131
- 278308006
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C2348558
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Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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MTHU008876 (LOINC Version 232)
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525.9 (ICD-9-CM Version 2011)
CL425202 (UMLS CUI 2011AA)
C0877046 (UMLS CUI 2011AA)
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10048762 (MedDRA 14.1)
E11594 (CTCAE 1105E)
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6493001 (SNOMED CT 2011_0131)
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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)
392521001 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0814606 (UMLS CUI 2011AA)
C0596204 (UMLS CUI 2011AA)
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CL414904 (UMLS CUI 2011AA)
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10033288 (MedDRA 14.1)
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73132005 (SNOMED CT 2011_0131)
10033942 (MedDRA 14.1)
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288556008 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
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C0392920 (UMLS CUI 2011AA)
150415003 (SNOMED CT 2011_0131)
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255560000 (SNOMED CT 2011_0131)
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372907000 (SNOMED CT 2011_0131)
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31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
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111151007 (SNOMED CT 2011_0131)
MTHU019429 (LOINC Version 232)
C1258800 (UMLS CUI 2011AA)
C0037663 (UMLS CUI 2011AA)
56234005 (SNOMED CT 2011_0131)
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395903002 (SNOMED CT 2011_0131)
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15240007 (SNOMED CT 2011_0131)
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26643006 (SNOMED CT 2011_0131)
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