ID

22432

Description

A Pilot Study of Bone Mineral Density in Postmenopausal Women After Treatment for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00399321

Link

https://clinicaltrials.gov/show/NCT00399321

Keywords

Versions (1)
  1. 6/3/17 6/3/17 -
Uploaded on

June 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Postmenopausal Bone Loss NCT00399321

English

Eligibility Postmenopausal Bone Loss NCT00399321

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented diagnosis of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
last menstrual period occurring more than 5 years ago
Description

Menstrual cycle Last | Past Year Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0025329
UMLS CUI [1,2]
C1517741
UMLS CUI [2,1]
C1444637
UMLS CUI [2,2]
C0439234
UMLS CUI [2,3]
C1265611
non-metastatic breast cancer tumor with the diagnosis of tis, tl-t4, n0-3, m0
Description

Breast Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3258246
dcis is allowed, but lcis (only) is not
Description

Noninfiltrating Intraductal Carcinoma | Lobular carcinoma in situ of breast

Data type

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2]
C0279563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any metabolic bone disease other than postmenopausal osteoporosis or osteopenia
Description

Metabolic Bone Disorder | Osteoporosis, Postmenopausal | Osteopenia Postmenopausal

Data type

boolean

Alias
UMLS CUI [1]
C0005944
UMLS CUI [2]
C0029458
UMLS CUI [3,1]
C0029453
UMLS CUI [3,2]
C0232970
use of systemic gonadal hormonal medications or supplements within the past 24 months
Description

Pharmaceutical Preparations Gonadal Hormones Systemic | Supplement Gonadal Hormones Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0301819
UMLS CUI [1,3]
C0205373
UMLS CUI [2,1]
C2348609
UMLS CUI [2,2]
C0301819
UMLS CUI [2,3]
C0205373
prior use of tamoxifen or raloxifene is permitted if the medication was discontinued more than 24 months prior to the diagnosis of breast cancer.
Description

Tamoxifen Discontinued | Raloxifene Discontinued

Data type

boolean

Alias
UMLS CUI [1,1]
C0039286
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0244404
UMLS CUI [2,2]
C1444662
no adjuvant antiestrogen, antineoplastic, therapies are permitted on study.
Description

Antioestrogen therapy Adjuvant | Antineoplastic Drug/Agent Therapy Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0854638
UMLS CUI [1,2]
C1522673
UMLS CUI [2,1]
C2346834
UMLS CUI [2,2]
C1522673
chronic use of systemic steroids for disease process other than breast cancer chemotherapy premedication or antiemetics
Description

Systemic steroids chronic | Chemotherapy Premedication Breast Carcinoma | Antiemetics

Data type

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0033045
UMLS CUI [2,3]
C0678222
UMLS CUI [3]
C0003297
history of rheumatoid arthritis, ankylosing spondylitis, hyperparathyroidism, renal osteodystrophy, moderate to severe inflammatory or autoimmune disease or newly diagnosed thyroid condition requiring titration of medications.
Description

Rheumatoid Arthritis | Ankylosing spondylitis | Hyperparathyroidism | Renal Osteodystrophy | Inflammatory disorder Moderate | Inflammatory disorder Severe | Autoimmune Diseases Moderate | Autoimmune Diseases Severe | Thyroid Diseases Requirement Titration Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0038013
UMLS CUI [3]
C0020502
UMLS CUI [4]
C0035086
UMLS CUI [5,1]
C1290884
UMLS CUI [5,2]
C0205081
UMLS CUI [6,1]
C1290884
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0004364
UMLS CUI [7,2]
C0205081
UMLS CUI [8,1]
C0004364
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0040128
UMLS CUI [9,2]
C1514873
UMLS CUI [9,3]
C0162621
UMLS CUI [9,4]
C0013227
lobular carcinoma in situ or stage iv breast cancer and patients with a concurrently active second malignancy other then adequately treated non-melanoma skin cancers or in situ cervical cancer.
Description

Lobular carcinoma in situ of breast | Breast Carcinoma TNM clinical staging | Neoplasms, Second Primary | Skin carcinoma Treated | Carcinoma in situ of uterine cervix Treated

Data type

boolean

Alias
UMLS CUI [1]
C0279563
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0085183
UMLS CUI [4,1]
C0699893
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0851140
UMLS CUI [5,2]
C1522326
participation in other clinical trials that are measuring bmd as a study parameter
Description

Study Subject Participation Status | Bone Mineral Density Test

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0177804
patients with conditions that are expected to distort bmd reading and make dexa results unreliable
Description

Condition Interferes with Bone Mineral Density Test | Condition Interferes with DEXA Result

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0177804
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1510486
UMLS CUI [2,4]
C1274040
patients with concurrent medical or psychiatric conditions that would keep them from understanding and complying with this clinical trial.
Description

Medical condition Preventing Protocol Compliance | Mental condition Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
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Similar models

Eligibility Postmenopausal Bone Loss NCT00399321

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
documented diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Menstrual cycle Last | Past Year Quantity
Item
last menstrual period occurring more than 5 years ago
boolean
C0025329 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1444637 (UMLS CUI [2,1])
C0439234 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Breast Carcinoma TNM clinical staging
Item
non-metastatic breast cancer tumor with the diagnosis of tis, tl-t4, n0-3, m0
boolean
C0678222 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Noninfiltrating Intraductal Carcinoma | Lobular carcinoma in situ of breast
Item
dcis is allowed, but lcis (only) is not
boolean
C0007124 (UMLS CUI [1])
C0279563 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Metabolic Bone Disorder | Osteoporosis, Postmenopausal | Osteopenia Postmenopausal
Item
any metabolic bone disease other than postmenopausal osteoporosis or osteopenia
boolean
C0005944 (UMLS CUI [1])
C0029458 (UMLS CUI [2])
C0029453 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
Pharmaceutical Preparations Gonadal Hormones Systemic | Supplement Gonadal Hormones Systemic
Item
use of systemic gonadal hormonal medications or supplements within the past 24 months
boolean
C0013227 (UMLS CUI [1,1])
C0301819 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C2348609 (UMLS CUI [2,1])
C0301819 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
Tamoxifen Discontinued | Raloxifene Discontinued
Item
prior use of tamoxifen or raloxifene is permitted if the medication was discontinued more than 24 months prior to the diagnosis of breast cancer.
boolean
C0039286 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0244404 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Antioestrogen therapy Adjuvant | Antineoplastic Drug/Agent Therapy Adjuvant
Item
no adjuvant antiestrogen, antineoplastic, therapies are permitted on study.
boolean
C0854638 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C2346834 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
Systemic steroids chronic | Chemotherapy Premedication Breast Carcinoma | Antiemetics
Item
chronic use of systemic steroids for disease process other than breast cancer chemotherapy premedication or antiemetics
boolean
C2825233 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0033045 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C0003297 (UMLS CUI [3])
Rheumatoid Arthritis | Ankylosing spondylitis | Hyperparathyroidism | Renal Osteodystrophy | Inflammatory disorder Moderate | Inflammatory disorder Severe | Autoimmune Diseases Moderate | Autoimmune Diseases Severe | Thyroid Diseases Requirement Titration Pharmaceutical Preparations
Item
history of rheumatoid arthritis, ankylosing spondylitis, hyperparathyroidism, renal osteodystrophy, moderate to severe inflammatory or autoimmune disease or newly diagnosed thyroid condition requiring titration of medications.
boolean
C0003873 (UMLS CUI [1])
C0038013 (UMLS CUI [2])
C0020502 (UMLS CUI [3])
C0035086 (UMLS CUI [4])
C1290884 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C1290884 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0004364 (UMLS CUI [7,1])
C0205081 (UMLS CUI [7,2])
C0004364 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0040128 (UMLS CUI [9,1])
C1514873 (UMLS CUI [9,2])
C0162621 (UMLS CUI [9,3])
C0013227 (UMLS CUI [9,4])
Lobular carcinoma in situ of breast | Breast Carcinoma TNM clinical staging | Neoplasms, Second Primary | Skin carcinoma Treated | Carcinoma in situ of uterine cervix Treated
Item
lobular carcinoma in situ or stage iv breast cancer and patients with a concurrently active second malignancy other then adequately treated non-melanoma skin cancers or in situ cervical cancer.
boolean
C0279563 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0085183 (UMLS CUI [3])
C0699893 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0851140 (UMLS CUI [5,1])
C1522326 (UMLS CUI [5,2])
Study Subject Participation Status | Bone Mineral Density Test
Item
participation in other clinical trials that are measuring bmd as a study parameter
boolean
C2348568 (UMLS CUI [1])
C0177804 (UMLS CUI [2])
Condition Interferes with Bone Mineral Density Test | Condition Interferes with DEXA Result
Item
patients with conditions that are expected to distort bmd reading and make dexa results unreliable
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0177804 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1510486 (UMLS CUI [2,3])
C1274040 (UMLS CUI [2,4])
Medical condition Preventing Protocol Compliance | Mental condition Preventing Protocol Compliance
Item
patients with concurrent medical or psychiatric conditions that would keep them from understanding and complying with this clinical trial.
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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