ID

43863

Description

Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00703417

Link

https://clinicaltrials.gov/show/NCT00703417

Keywords

Versions (2)
  1. 5/21/17 5/21/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoporosis NCT00703417

English

Eligibility Osteoporosis NCT00703417

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal female, 55-75 years old
Description

postmenopausal female

Data type

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0086287
history of type ii diabetes, as defined by the american diabetes association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin
Description

type 2 diabetes, american diabetes association

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1705019
body mass index (bmi) of 19-35
Description

bmi

Data type

boolean

Alias
UMLS CUI [1]
C1305855
able to move without walkers and without a history of long periods (>3 months) of inactivity
Description

able to move

Data type

boolean

Alias
UMLS CUI [1]
C0578670
additional inclusion criteria for fracture participants: fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. all fractures will be verified by radiographs.
Description

fractures

Data type

boolean

Alias
UMLS CUI [1]
C0016658
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe neuropathic disease such as neurogenic osteoarthropathies (i.e., charcot joints) of the foot
Description

neuropathic disease

Data type

boolean

Alias
UMLS CUI [1]
C0003892
steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism
Description

steroid use, comorbidity affecting osteoporosis development

Data type

boolean

Alias
UMLS CUI [1]
C0281991
UMLS CUI [2,1]
C0029456
UMLS CUI [2,2]
C1527148
UMLS CUI [2,3]
C0009488
diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment
Description

bone metabolism disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005944
chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of vitamin a supplements 6 months prior
Description

antacids, estrogen, steroids, anticonvulsants, anticoagulants, vitamin a

Data type

boolean

Alias
UMLS CUI [1]
C0003138
UMLS CUI [2]
C0279494
UMLS CUI [3]
C0038317
UMLS CUI [4]
C0003286
UMLS CUI [5]
C0003280
UMLS CUI [6]
C0042839
diabetic patients on rosiglitazone or pioglitazone medications
Description

rosiglitazone, pioglitazone

Data type

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0071097
high energy trauma, e.g., due to motor vehicle accidents
Description

high energy trauma

Data type

boolean

Alias
UMLS CUI [1]
C3263723
pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs
Description

pathologic fractures

Data type

boolean

Alias
UMLS CUI [1]
C0016663
history of fluoride, bisphosphonate, calcitonin or tamoxifen use
Description

fluoride, bisphosphonate, calcitonin, tamoxifen

Data type

boolean

Alias
UMLS CUI [1]
C0016327
UMLS CUI [2]
C0012544
UMLS CUI [3]
C0006668
UMLS CUI [4]
C0039286
history of unstable cardiovascular disease or uncontrolled hypertension
Description

cardiovascular disease, uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1868885
mri contraindications
Description

mri contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0522473
body mass index greater than 35
Description

bmi

Data type

boolean

Alias
UMLS CUI [1]
C1305855
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Similar models

Eligibility Osteoporosis NCT00703417

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
postmenopausal female
Item
postmenopausal female, 55-75 years old
boolean
C0232970 (UMLS CUI [1,1])
C0086287 (UMLS CUI [1,2])
type 2 diabetes, american diabetes association
Item
history of type ii diabetes, as defined by the american diabetes association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin
boolean
C0011860 (UMLS CUI [1,1])
C1705019 (UMLS CUI [1,2])
bmi
Item
body mass index (bmi) of 19-35
boolean
C1305855 (UMLS CUI [1])
able to move
Item
able to move without walkers and without a history of long periods (>3 months) of inactivity
boolean
C0578670 (UMLS CUI [1])
fractures
Item
additional inclusion criteria for fracture participants: fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. all fractures will be verified by radiographs.
boolean
C0016658 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
neuropathic disease
Item
severe neuropathic disease such as neurogenic osteoarthropathies (i.e., charcot joints) of the foot
boolean
C0003892 (UMLS CUI [1])
steroid use, comorbidity affecting osteoporosis development
Item
steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism
boolean
C0281991 (UMLS CUI [1])
C0029456 (UMLS CUI [2,1])
C1527148 (UMLS CUI [2,2])
C0009488 (UMLS CUI [2,3])
bone metabolism disorder
Item
diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment
boolean
C0005944 (UMLS CUI [1])
antacids, estrogen, steroids, anticonvulsants, anticoagulants, vitamin a
Item
chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of vitamin a supplements 6 months prior
boolean
C0003138 (UMLS CUI [1])
C0279494 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
C0003286 (UMLS CUI [4])
C0003280 (UMLS CUI [5])
C0042839 (UMLS CUI [6])
rosiglitazone, pioglitazone
Item
diabetic patients on rosiglitazone or pioglitazone medications
boolean
C0289313 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
high energy trauma
Item
high energy trauma, e.g., due to motor vehicle accidents
boolean
C3263723 (UMLS CUI [1])
pathologic fractures
Item
pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs
boolean
C0016663 (UMLS CUI [1])
fluoride, bisphosphonate, calcitonin, tamoxifen
Item
history of fluoride, bisphosphonate, calcitonin or tamoxifen use
boolean
C0016327 (UMLS CUI [1])
C0012544 (UMLS CUI [2])
C0006668 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
cardiovascular disease, uncontrolled hypertension
Item
history of unstable cardiovascular disease or uncontrolled hypertension
boolean
C0007222 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
mri contraindication
Item
mri contraindications
boolean
C0024485 (UMLS CUI [1,1])
C0522473 (UMLS CUI [1,2])
bmi
Item
body mass index greater than 35
boolean
C1305855 (UMLS CUI [1])
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