ID

36736

Description

A One-year Trial Evaluating the Impact of Pioglitazone Versus Linagliptin on Bone Mineral Density; ODM derived from: https://clinicaltrials.gov/show/NCT02429232

Link

https://clinicaltrials.gov/show/NCT02429232

Keywords

Versions (1)
  1. 6/5/19 6/5/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 5, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Osteoporosis NCT02429232

English

Eligibility Osteoporosis NCT02429232

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or postmenopausal female ≥ 40 years of age at visit 1
Description

Gender | Postmenopausal state | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0001779
documentation of type 2 diabetes mellitus as evidenced by one or more of the following criteria:
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
1. with typical symptoms and random blood sugar ≥ 200 mg/dl
Description

Symptoms Typical | Blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3538928
UMLS CUI [2]
C0392201
2. 8-hour fasting blood sugar ≥ 126 mg/dl
Description

Fasting blood glucose measurement Hour Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0428568
UMLS CUI [1,2]
C0439227
UMLS CUI [1,3]
C1265611
3. oral glucose tolerance test ≥ 200 mg/dl
Description

Oral Glucose Tolerance Test

Data type

boolean

Alias
UMLS CUI [1]
C0029161
4. hba1c≥ 6.5%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
only receiving oral anti-diabetic drugs (excluding tzds or dpp-4 inhibitors) till visit 1 at least 3 months, and the hba1c is between 7.0~8.5 % in recent 3 months.
Description

Antidiabetics Oral | Exception Thiazolidinediones | Exception Dipeptidyl-Peptidase IV Inhibitors | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1257987
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1827106
UMLS CUI [4]
C0474680
written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Description

Informed Consent | Informed Consent Patient Representative | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
dm on oral anti-diabetic drugs less than 3 months.
Description

Diabetes Mellitus | Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
receiving treatment of tzds or dpp-4 inhibitors prior to this study.
Description

Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C1827106
presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
Description

Condition compromises Patient safety | Abnormality compromises Patient safety | Condition compromises Data Quality | Abnormality compromises Data Quality

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0242483
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C0242483
ast, alt over 2.5 times of the upper limit.
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
chronic kidney disease, stage 4 and 5.
Description

Chronic kidney disease stage

Data type

boolean

Alias
UMLS CUI [1]
C2074731
congestive heart failure, nyha class iii, iv
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
history of osteoporosis. (t score < -2.5)
Description

Osteoporosis T score

Data type

boolean

Alias
UMLS CUI [1,1]
C0029456
UMLS CUI [1,2]
C3854607
serum 25(oh)vit d < 20ng/ml
Description

Vitamin D, 25-hydroxy measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373558
any diseases known to affect bone metabolism:
Description

Disease Affecting Bone metabolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596204
abnormal thyroid function or history of hyperthyroidism, cushing's syndrome, hypogonadism, acromegaly, history of hypopituitarism or status post pituitary surgery and/or radiotherapy, hematopoietic disorders.
Description

Thyroid function tests abnormal | Hyperthyroidism | Cushing Syndrome | Hypogonadism | Acromegaly | Hypopituitarism | Status post Pituitary gland surgery | Status post Therapeutic radiology procedure | Hematological Disease

Data type

boolean

Alias
UMLS CUI [1]
C0476414
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0010481
UMLS CUI [4]
C0020619
UMLS CUI [5]
C0001206
UMLS CUI [6]
C0020635
UMLS CUI [7,1]
C0231290
UMLS CUI [7,2]
C0871087
UMLS CUI [8,1]
C0231290
UMLS CUI [8,2]
C1522449
UMLS CUI [9]
C0018939
diabetic macular edema (dme).
Description

Diabetic macular edema

Data type

boolean

Alias
UMLS CUI [1]
C0730285
moderate to severe diabetic retinopathy.
Description

Diabetic Retinopathy Moderate | Diabetic Retinopathy Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0011884
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0011884
UMLS CUI [2,2]
C0205082
history of fracture over lumbar spine or hip joint or femoral head or forearm or any site of bone fracture undergoes treatment currently.
Description

Fracture of lumbar spine | Fracture Hip Joint | Fracture Head of femur | Fracture of forearm | Therapy Fracture Site Any

Data type

boolean

Alias
UMLS CUI [1]
C0262544
UMLS CUI [2,1]
C0016658
UMLS CUI [2,2]
C0019558
UMLS CUI [3,1]
C0016658
UMLS CUI [3,2]
C0015813
UMLS CUI [4]
C1305215
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0016658
UMLS CUI [5,3]
C1515974
UMLS CUI [5,4]
C1552551
who had taken any of the following medications prior to screening:
Description

Pharmaceutical Preparations Intake Before Screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0220908
corticosteroid, heparin, anticonvulsants, aluminum-containing antacid, proton pump inhibitor, immunosuppressant user within 3 months. bisphosphonate, systemic fluoride treatment, pht analogue, calcitonin, denosumab, strontium ranelate, hormone replacement therapy (androgen/estrogen/progesterone, thyroxine, growth hormone), selective estrogen receptor modulator /serm (tamoxifene, raloxifene), selective tissue estrogenic activity regulator /stear (tibolone), aromatase inhibitors within 1 year.
Description

Adrenal Cortex Hormones | heparin | Anticonvulsants | Aluminum-based antacid | Proton Pump Inhibitors | Immunosuppressive Agents | Diphosphonates | Fluoride Systemic therapy | Phenytoin Analogue | Calcitonin | denosumab | strontium ranelate | Hormone replacement therapy | Androgens | Estrogens | Progesterone | thyroxine | Growth Hormone | Selective Estrogen Receptor Modulators | Tamoxifen | Raloxifene | tibolone | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2]
C0019134
UMLS CUI [3]
C0003286
UMLS CUI [4]
C0304540
UMLS CUI [5]
C0358591
UMLS CUI [6]
C0021081
UMLS CUI [7]
C0012544
UMLS CUI [8,1]
C0016327
UMLS CUI [8,2]
C1515119
UMLS CUI [9,1]
C0031507
UMLS CUI [9,2]
C0243071
UMLS CUI [10]
C0006668
UMLS CUI [11]
C1690432
UMLS CUI [12]
C0936139
UMLS CUI [13]
C0282402
UMLS CUI [14]
C0002844
UMLS CUI [15]
C0014939
UMLS CUI [16]
C0033308
UMLS CUI [17]
C0040165
UMLS CUI [18]
C0037663
UMLS CUI [19]
C0732611
UMLS CUI [20]
C0039286
UMLS CUI [21]
C0244404
UMLS CUI [22]
C0076660
UMLS CUI [23]
C0593802
history of cancer.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
bed-ridden patients.
Description

Patients Bed-ridden

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0425251
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Similar models

Eligibility Osteoporosis NCT02429232

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Postmenopausal state | Age
Item
male or postmenopausal female ≥ 40 years of age at visit 1
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Diabetes Mellitus, Non-Insulin-Dependent
Item
documentation of type 2 diabetes mellitus as evidenced by one or more of the following criteria:
boolean
C0011860 (UMLS CUI [1])
Symptoms Typical | Blood glucose measurement
Item
1. with typical symptoms and random blood sugar ≥ 200 mg/dl
boolean
C1457887 (UMLS CUI [1,1])
C3538928 (UMLS CUI [1,2])
C0392201 (UMLS CUI [2])
Fasting blood glucose measurement Hour Quantity
Item
2. 8-hour fasting blood sugar ≥ 126 mg/dl
boolean
C0428568 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Oral Glucose Tolerance Test
Item
3. oral glucose tolerance test ≥ 200 mg/dl
boolean
C0029161 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c≥ 6.5%
boolean
C0474680 (UMLS CUI [1])
Antidiabetics Oral | Exception Thiazolidinediones | Exception Dipeptidyl-Peptidase IV Inhibitors | Hemoglobin A1c measurement
Item
only receiving oral anti-diabetic drugs (excluding tzds or dpp-4 inhibitors) till visit 1 at least 3 months, and the hba1c is between 7.0~8.5 % in recent 3 months.
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1257987 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1827106 (UMLS CUI [3,2])
C0474680 (UMLS CUI [4])
Informed Consent | Informed Consent Patient Representative | Protocol Compliance
Item
written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus | Antidiabetics Oral
Item
dm on oral anti-diabetic drugs less than 3 months.
boolean
C0011849 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors
Item
receiving treatment of tzds or dpp-4 inhibitors prior to this study.
boolean
C1257987 (UMLS CUI [1])
C1827106 (UMLS CUI [2])
Condition compromises Patient safety | Abnormality compromises Patient safety | Condition compromises Data Quality | Abnormality compromises Data Quality
Item
presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0242483 (UMLS CUI [3,3])
C1704258 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0242483 (UMLS CUI [4,3])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast, alt over 2.5 times of the upper limit.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Chronic kidney disease stage
Item
chronic kidney disease, stage 4 and 5.
boolean
C2074731 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure, nyha class iii, iv
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Osteoporosis T score
Item
history of osteoporosis. (t score < -2.5)
boolean
C0029456 (UMLS CUI [1,1])
C3854607 (UMLS CUI [1,2])
Vitamin D, 25-hydroxy measurement
Item
serum 25(oh)vit d < 20ng/ml
boolean
C0373558 (UMLS CUI [1])
Disease Affecting Bone metabolism
Item
any diseases known to affect bone metabolism:
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
Thyroid function tests abnormal | Hyperthyroidism | Cushing Syndrome | Hypogonadism | Acromegaly | Hypopituitarism | Status post Pituitary gland surgery | Status post Therapeutic radiology procedure | Hematological Disease
Item
abnormal thyroid function or history of hyperthyroidism, cushing's syndrome, hypogonadism, acromegaly, history of hypopituitarism or status post pituitary surgery and/or radiotherapy, hematopoietic disorders.
boolean
C0476414 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
C0010481 (UMLS CUI [3])
C0020619 (UMLS CUI [4])
C0001206 (UMLS CUI [5])
C0020635 (UMLS CUI [6])
C0231290 (UMLS CUI [7,1])
C0871087 (UMLS CUI [7,2])
C0231290 (UMLS CUI [8,1])
C1522449 (UMLS CUI [8,2])
C0018939 (UMLS CUI [9])
Diabetic macular edema
Item
diabetic macular edema (dme).
boolean
C0730285 (UMLS CUI [1])
Diabetic Retinopathy Moderate | Diabetic Retinopathy Severe
Item
moderate to severe diabetic retinopathy.
boolean
C0011884 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0011884 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Fracture of lumbar spine | Fracture Hip Joint | Fracture Head of femur | Fracture of forearm | Therapy Fracture Site Any
Item
history of fracture over lumbar spine or hip joint or femoral head or forearm or any site of bone fracture undergoes treatment currently.
boolean
C0262544 (UMLS CUI [1])
C0016658 (UMLS CUI [2,1])
C0019558 (UMLS CUI [2,2])
C0016658 (UMLS CUI [3,1])
C0015813 (UMLS CUI [3,2])
C1305215 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C0016658 (UMLS CUI [5,2])
C1515974 (UMLS CUI [5,3])
C1552551 (UMLS CUI [5,4])
Pharmaceutical Preparations Intake Before Screening
Item
who had taken any of the following medications prior to screening:
boolean
C0013227 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
Adrenal Cortex Hormones | heparin | Anticonvulsants | Aluminum-based antacid | Proton Pump Inhibitors | Immunosuppressive Agents | Diphosphonates | Fluoride Systemic therapy | Phenytoin Analogue | Calcitonin | denosumab | strontium ranelate | Hormone replacement therapy | Androgens | Estrogens | Progesterone | thyroxine | Growth Hormone | Selective Estrogen Receptor Modulators | Tamoxifen | Raloxifene | tibolone | Aromatase Inhibitors
Item
corticosteroid, heparin, anticonvulsants, aluminum-containing antacid, proton pump inhibitor, immunosuppressant user within 3 months. bisphosphonate, systemic fluoride treatment, pht analogue, calcitonin, denosumab, strontium ranelate, hormone replacement therapy (androgen/estrogen/progesterone, thyroxine, growth hormone), selective estrogen receptor modulator /serm (tamoxifene, raloxifene), selective tissue estrogenic activity regulator /stear (tibolone), aromatase inhibitors within 1 year.
boolean
C0001617 (UMLS CUI [1])
C0019134 (UMLS CUI [2])
C0003286 (UMLS CUI [3])
C0304540 (UMLS CUI [4])
C0358591 (UMLS CUI [5])
C0021081 (UMLS CUI [6])
C0012544 (UMLS CUI [7])
C0016327 (UMLS CUI [8,1])
C1515119 (UMLS CUI [8,2])
C0031507 (UMLS CUI [9,1])
C0243071 (UMLS CUI [9,2])
C0006668 (UMLS CUI [10])
C1690432 (UMLS CUI [11])
C0936139 (UMLS CUI [12])
C0282402 (UMLS CUI [13])
C0002844 (UMLS CUI [14])
C0014939 (UMLS CUI [15])
C0033308 (UMLS CUI [16])
C0040165 (UMLS CUI [17])
C0037663 (UMLS CUI [18])
C0732611 (UMLS CUI [19])
C0039286 (UMLS CUI [20])
C0244404 (UMLS CUI [21])
C0076660 (UMLS CUI [22])
C0593802 (UMLS CUI [23])
Malignant Neoplasms
Item
history of cancer.
boolean
C0006826 (UMLS CUI [1])
Patients Bed-ridden
Item
bed-ridden patients.
boolean
C0030705 (UMLS CUI [1,1])
C0425251 (UMLS CUI [1,2])
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