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| ID | Type | Description | Link |
|---|---|---|---|
| H-28679 | Other Identifier | IRB number |
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The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected group of young patients with normal kidney function.
Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it. Vitamin D must then be activated by both the liver and the kidneys to perform its function of maintaining strong bones and helping to prevent heart disease, infection, diabetes and cancer. Reduced kidney activation of Vitamin D occurs with advanced age and with all kidney diseases. We have identified a small group of patients who appear to have reduced ability of the kidneys to activate vitamin D, even though they are young and do not have chronic kidney disease. In these patients, we are comparing the ability of their kidneys to activate Vitamin D to that of healthy controls. To stimulate the kidneys to activate Vitamin D, we are giving parathyroid hormone intravenously over 8 hours and collecting blood and urine at baseline, 4 and 8 hours. This type of parathyroid infusion does not cause side effects. The gene that controls this activation is also being studied (by a simple blood test) to look for abnormalities. We are now actively recruiting healthy controls for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| teriparatide control | Active Comparator | control subject |
|
| Teriparatide Patient | Experimental | Patient with secondary hyperparathyroidism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls" |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours | 1,25-D was measured at baseline, 4 and 8 hours after PTH infusion | baseline, 4 and 8 hours after start of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Mutations in CYP27B1 | CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data | blood samples taken at baseline and sequenced over several days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Streeten, MD | Division of Endocrinology, University of Maryland School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Medicine Division of Endocrinology | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23186957 | Result | Streeten EA, Rogstad AS, Flammer KM, Zarbalian K, Ryan K, Horwitz M, Holick MF, Shelton J. Reduced parathyroid hormone-stimulated 1,25-dihydroxyvitamin d production in vitamin d sufficient postmenoposual women with low bone mass and idiopathic secondary hyperparathyroidism. Endocr Pract. 2013 Jan-Feb;19(1):91-9. doi: 10.4158/EP12151.OR. |
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Of 11 "controls" enrolled, 6 completed the study and 5 dropped out because they didn't want to do the parathyroid hormone (PTH) infusion. Of 9 "patients" recruited, 6 completed the study. The others were excluded after their screening labs showed that their renal function was below the inclusion criteria.
All in the "patient" group were recruited from the Metabolic Bone Clinic at U Md, except one, who was recruited from prior participation in the Amish Family Osteoporosis Study, recruited from 3/15/07-11/14/08
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| ID | Title | Description |
|---|---|---|
| FG000 | Controls | controls with normal PTH |
| FG001 | Patient Group | patients with secondary hyperparathyroidism |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Controls | controls with normal PTH |
| BG001 | Patient Group | patients with secondary hyperparathyroidism |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Level of Activated Vitamin D (1,25-dihydroxyvitamin D) After Parathyroid Hormone Infusion at Baseline, 4 and 8 Hours | 1,25-D was measured at baseline, 4 and 8 hours after PTH infusion | The final analysis was made on participants with glomerular filtration rate (GFR) of 70 and above since <70, 1,25-D production decreases. After study completion, it was noted that one participant in each group (patient and control) had GFR<70 so these two participants were excluded from final analysis. | Posted | Mean | Standard Deviation | pg/ml | baseline, 4 and 8 hours after start of infusion |
|
During PTH infusion, 2 participants, one in patient and one in control groups had one episode of vomiting each.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controls | controls with normal PTH |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | Systematic Assessment | One patient and one control each had one episode of vomiting during the PTH infusion. Both continued the full 8 hrs of infusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth A Streeten, MD | University of Maryland School of Medicine | 410-328-6219 | estreete@medicine.umaryland.edu |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Controls without secondary hyperparathyroidism
|
|
|
| Secondary | The Number of Patients With Mutations in CYP27B1 | CYP27B1 gene (the gene for 25-hydroxyvitamin D-1-alpha hydroxylase) was sequenced for all in patient group and compared with published control data | All patients were sequenced and compared to published control data. Controls were not sequenced for cost reasons | Posted | Number | participants | blood samples taken at baseline and sequenced over several days |
|
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Patient Group | patients with secondary hyperparathyroidism | 0 | 9 | 1 | 9 |
|
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| D044342 |
| Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |