ID

43927

Description

Effect of Diabetic Medications on Bone Metabolism; ODM derived from: https://clinicaltrials.gov/show/NCT00467285

Link

https://clinicaltrials.gov/show/NCT00467285

Keywords

Versions (2)
  1. 5/29/17 5/29/17 -
  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 NCT00467285

English

Eligibility Osteoporosis NCT00467285

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 30-55 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
gender: men and women
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
ethnicity: all ethnic groups
Description

Ethnic group All

Data type

boolean

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0444868
140 subjects with diabetes and no pioglitazone (recently started i.e. less than 3 months as well as those who have just initiated pioglitazone treatment)
Description

Study Subject Quantity | Diabetes Mellitus | Pioglitazone Absent | Pioglitazone Initiation

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0011849
UMLS CUI [3,1]
C0071097
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0071097
UMLS CUI [4,2]
C1704686
140 control subjects (subjects with diabetes and not on pioglitazone) will be included
Description

Control Group Study Subject Quantity | Diabetes Mellitus | Pioglitazone Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0011849
UMLS CUI [3,1]
C0071097
UMLS CUI [3,2]
C0332197
the control subjects will be chosen to match age, sex, ethnicity and comparable smoking and alcohol history
Description

Control Group Study Subject | Match Age | Match Gender | Match Ethnic group | Tobacco use Similarity | Alcohol consumption Similarity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0681850
UMLS CUI [2,1]
C1708943
UMLS CUI [2,2]
C0001779
UMLS CUI [3,1]
C1708943
UMLS CUI [3,2]
C0079399
UMLS CUI [4,1]
C1708943
UMLS CUI [4,2]
C0015031
UMLS CUI [5,1]
C0543414
UMLS CUI [5,2]
C2348205
UMLS CUI [6,1]
C0001948
UMLS CUI [6,2]
C2348205
to avoid confusion factor of vitamin d and calcium intake, all the subjects will be given vitamin d and calcium supplements (usda recommended doses)
Description

Vitamin D Administration | Calcium supplement Administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0042866
UMLS CUI [1,2]
C1533734
UMLS CUI [2,1]
C3540037
UMLS CUI [2,2]
C1533734
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are unable or unwilling yo give informed consent
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
immobilized or bed bound subject
Description

Immobilization | Bedridden

Data type

boolean

Alias
UMLS CUI [1]
C0020944
UMLS CUI [2]
C0741453
subjects wil known diseases associated with disordered bone metabolism such as chronic renal insufficiency, chronic steroid use, primary hyperparathyroidism, untreated subclinical or clinical hyperthyroidism and paget's disease. to identify subjects with decreased glomerular filtration rate (gfr) even if creatinine is normal will be excluded (at the proposed study site, routine bm includes calculated gfr from the chemistry lab)
Description

Disease Associated with Metabolic Bone Disorder | Chronic Kidney Insufficiency | Steroid use chronic | Hyperparathyroidism, Primary | Hyperthyroidism untreated | Paget's Disease | Decreased glomerular filtration rate | Creatinine normal | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0005944
UMLS CUI [2]
C0403447
UMLS CUI [3,1]
C0281991
UMLS CUI [3,2]
C0205191
UMLS CUI [4]
C0221002
UMLS CUI [5,1]
C0020550
UMLS CUI [5,2]
C0332155
UMLS CUI [6]
C1368019
UMLS CUI [7]
C0853068
UMLS CUI [8]
C0860945
UMLS CUI [9]
C0017654
patients on medications that will alter bone metabolism will be excluded. they are glucocorticoids, gonadal hormones (testosterone in men and estrogen in women).
Description

Pharmaceutical Preparations Changing Bone metabolism | Glucocorticoids | Gonadal Hormones | Testosterone | Estrogens

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0596204
UMLS CUI [2]
C0017710
UMLS CUI [3]
C0301819
UMLS CUI [4]
C0039601
UMLS CUI [5]
C0014939
subjects with known history of chronic pancreatitis, pancreatectomy or malabsorption syndromes to avoid confounding factors known to affect vitamin d metabolism and indirectly bone mineral metabolism.
Description

Pancreatitis, Chronic | Pancreatectomy | Malabsorption Syndrome | Factor Affecting Vitamin D metabolic process | Factor Affecting Bone mineral metabolism

Data type

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0030279
UMLS CUI [3]
C0024523
UMLS CUI [4,1]
C1521761
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1159433
UMLS CUI [5,1]
C1521761
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0262950
UMLS CUI [5,4]
C0678715
female patients with perimenopause or menopause: history of hypogonadism (history of ovariectomy or postmenopausal women) to avoid bone turn over changes secondary to hypogonadism. perimenopausal women identifies by screening fsh and lh and excluding women with elevated fsh be excluded to avoid perimenopausal effect on bone turnover (women over 35 will still have a screening gonadal hormonal evaluation).
Description

Perimenopause | Menopause | Hypogonadism | Ovariectomy | Postmenopausal state | Bone remodeling Change Secondary to Hypogonadism | Perimenopausal state Follicle stimulating hormone measurement | Perimenopausal state Luteinizing hormone measurement | FSH increased | Gender Age Gonadal Hormones Evaluation

Data type

boolean

Alias
UMLS CUI [1]
C0993589
UMLS CUI [2]
C0025320
UMLS CUI [3]
C0020619
UMLS CUI [4]
C0029936
UMLS CUI [5]
C0232970
UMLS CUI [6,1]
C0085268
UMLS CUI [6,2]
C0392747
UMLS CUI [6,3]
C0175668
UMLS CUI [6,4]
C0020619
UMLS CUI [7,1]
C3839366
UMLS CUI [7,2]
C0202022
UMLS CUI [8,1]
C3839366
UMLS CUI [8,2]
C0202123
UMLS CUI [9]
C0151679
UMLS CUI [10,1]
C0079399
UMLS CUI [10,2]
C0001779
UMLS CUI [10,3]
C0301819
UMLS CUI [10,4]
C1261322
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Similar models

Eligibility Osteoporosis NCT00467285

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 30-55 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
gender: men and women
boolean
C0079399 (UMLS CUI [1])
Ethnic group All
Item
ethnicity: all ethnic groups
boolean
C0015031 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Study Subject Quantity | Diabetes Mellitus | Pioglitazone Absent | Pioglitazone Initiation
Item
140 subjects with diabetes and no pioglitazone (recently started i.e. less than 3 months as well as those who have just initiated pioglitazone treatment)
boolean
C0681850 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0071097 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0071097 (UMLS CUI [4,1])
C1704686 (UMLS CUI [4,2])
Control Group Study Subject Quantity | Diabetes Mellitus | Pioglitazone Absent
Item
140 control subjects (subjects with diabetes and not on pioglitazone) will be included
boolean
C0009932 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2])
C0071097 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Control Group Study Subject | Match Age | Match Gender | Match Ethnic group | Tobacco use Similarity | Alcohol consumption Similarity
Item
the control subjects will be chosen to match age, sex, ethnicity and comparable smoking and alcohol history
boolean
C0009932 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1708943 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C1708943 (UMLS CUI [3,1])
C0079399 (UMLS CUI [3,2])
C1708943 (UMLS CUI [4,1])
C0015031 (UMLS CUI [4,2])
C0543414 (UMLS CUI [5,1])
C2348205 (UMLS CUI [5,2])
C0001948 (UMLS CUI [6,1])
C2348205 (UMLS CUI [6,2])
Vitamin D Administration | Calcium supplement Administration
Item
to avoid confusion factor of vitamin d and calcium intake, all the subjects will be given vitamin d and calcium supplements (usda recommended doses)
boolean
C0042866 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C3540037 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Informed Consent Unwilling
Item
patients who are unable or unwilling yo give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Immobilization | Bedridden
Item
immobilized or bed bound subject
boolean
C0020944 (UMLS CUI [1])
C0741453 (UMLS CUI [2])
Disease Associated with Metabolic Bone Disorder | Chronic Kidney Insufficiency | Steroid use chronic | Hyperparathyroidism, Primary | Hyperthyroidism untreated | Paget's Disease | Decreased glomerular filtration rate | Creatinine normal | Glomerular Filtration Rate
Item
subjects wil known diseases associated with disordered bone metabolism such as chronic renal insufficiency, chronic steroid use, primary hyperparathyroidism, untreated subclinical or clinical hyperthyroidism and paget's disease. to identify subjects with decreased glomerular filtration rate (gfr) even if creatinine is normal will be excluded (at the proposed study site, routine bm includes calculated gfr from the chemistry lab)
boolean
C0012634 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0005944 (UMLS CUI [1,3])
C0403447 (UMLS CUI [2])
C0281991 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0221002 (UMLS CUI [4])
C0020550 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
C1368019 (UMLS CUI [6])
C0853068 (UMLS CUI [7])
C0860945 (UMLS CUI [8])
C0017654 (UMLS CUI [9])
Pharmaceutical Preparations Changing Bone metabolism | Glucocorticoids | Gonadal Hormones | Testosterone | Estrogens
Item
patients on medications that will alter bone metabolism will be excluded. they are glucocorticoids, gonadal hormones (testosterone in men and estrogen in women).
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0596204 (UMLS CUI [1,3])
C0017710 (UMLS CUI [2])
C0301819 (UMLS CUI [3])
C0039601 (UMLS CUI [4])
C0014939 (UMLS CUI [5])
Pancreatitis, Chronic | Pancreatectomy | Malabsorption Syndrome | Factor Affecting Vitamin D metabolic process | Factor Affecting Bone mineral metabolism
Item
subjects with known history of chronic pancreatitis, pancreatectomy or malabsorption syndromes to avoid confounding factors known to affect vitamin d metabolism and indirectly bone mineral metabolism.
boolean
C0149521 (UMLS CUI [1])
C0030279 (UMLS CUI [2])
C0024523 (UMLS CUI [3])
C1521761 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1159433 (UMLS CUI [4,3])
C1521761 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0262950 (UMLS CUI [5,3])
C0678715 (UMLS CUI [5,4])
Perimenopause | Menopause | Hypogonadism | Ovariectomy | Postmenopausal state | Bone remodeling Change Secondary to Hypogonadism | Perimenopausal state Follicle stimulating hormone measurement | Perimenopausal state Luteinizing hormone measurement | FSH increased | Gender Age Gonadal Hormones Evaluation
Item
female patients with perimenopause or menopause: history of hypogonadism (history of ovariectomy or postmenopausal women) to avoid bone turn over changes secondary to hypogonadism. perimenopausal women identifies by screening fsh and lh and excluding women with elevated fsh be excluded to avoid perimenopausal effect on bone turnover (women over 35 will still have a screening gonadal hormonal evaluation).
boolean
C0993589 (UMLS CUI [1])
C0025320 (UMLS CUI [2])
C0020619 (UMLS CUI [3])
C0029936 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
C0085268 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C0175668 (UMLS CUI [6,3])
C0020619 (UMLS CUI [6,4])
C3839366 (UMLS CUI [7,1])
C0202022 (UMLS CUI [7,2])
C3839366 (UMLS CUI [8,1])
C0202123 (UMLS CUI [8,2])
C0151679 (UMLS CUI [9])
C0079399 (UMLS CUI [10,1])
C0001779 (UMLS CUI [10,2])
C0301819 (UMLS CUI [10,3])
C1261322 (UMLS CUI [10,4])
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