Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432939
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2007-02-06
Brief Title:
Primary Hyperparathyroidism Non-classical Manifestations
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Primary Hyperparathyroidism Non-classical Manifestations
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a research study to investigate cardiovascular health in people with mild hyperparathyroidism Previous research has suggested that severe hyperparathyroidism may be associated with abnormalities in the heart and blood vessels It is unclear whether mild hyperparathyroidism affects cardiovascular health This study involves the investigation of the heart and blood vessels of people with mild hyperparathyroidism Various non-invasive laboratory and radiological test to assess cardiovascular and bone health will be done at set intervals over the course of 2 years It is our hypothesis that patients with primary hyperparathyroidism will have subtle abnormalities in their cardiovascular system Using state-of-the art techniques that are sufficiently sensitive to detect these subtle abnormalities we will define cardiovascular features of this disease that have up to now eluded clear definition We expect taht the extent of these findings will be related to the severity of the underlying primary hyperparathyroidism We further hypothesize that cardiovascular manifestations may regress with successful cure of the hyperparathyroid state
Detailed Description:
This study involves a total of 4 visits over a 2-year period A variety of tests to evaluate your cardiovascular and bone health are performed The details and timing of the tests are explained below
VISIT 1 During the first visit a research doctor or assistant explains the procedures in detail and answers questions Blood is drawn about 1-2 tablespoons to confirm the diagnosis of hyperparathyroidism and get baseline blood values
VISIT 2-4 During the following visits a variety of procedures are performed to evaluate cardiovascular and bone health The details of the procedures and when they will be performed are outlined below
1 Blood tests are performed at each visit Approximately 1-2 tablespoons of blood will be drawn at each visit
2 A 24-hour urine collection is done 3 times during the 2 year study
3 Bone mineral density testing known as DXA is performed at baseline 12 and 24 months after enrollment
4 Carotid Ultrasound At the baseline visit 12 and 24 months after enrollment carotid ultrasound is performed
5 Echocardiogram At the baseline visit 12 and 24 months after enrollment an echocardiogram is performed
6 Endothelial Function At baseline 6 and 12 months after enrollment flow mediated dilation of the brachial artery is performed
VISIT 1 During the first visit a research doctor or assistant explains the procedures in detail and answers questions Blood is drawn about 1-2 tablespoons to confirm the diagnosis of hyperparathyroidism and get baseline blood values
VISIT 2-4 During the following visits a variety of procedures are performed to evaluate cardiovascular and bone health The details of the procedures and when they will be performed are outlined below
1 Blood tests are performed at each visit Approximately 1-2 tablespoons of blood will be drawn at each visit
2 A 24-hour urine collection is done 3 times during the 2 year study
3 Bone mineral density testing known as DXA is performed at baseline 12 and 24 months after enrollment
4 Carotid Ultrasound At the baseline visit 12 and 24 months after enrollment carotid ultrasound is performed
5 Echocardiogram At the baseline visit 12 and 24 months after enrollment an echocardiogram is performed
6 Endothelial Function At baseline 6 and 12 months after enrollment flow mediated dilation of the brachial artery is performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK066329 | NIH | None | httpsreporternihgovquickSearchR01DK066329 |