Primary Hyperparathyroidism: Non-classical Manifestations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Columbia University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shonni J. Silverberg, Columbia University
ClinicalTrials.gov Identifier:
NCT00432939
First received: February 6, 2007
Last updated: August 7, 2012
Last verified: August 2012

February 6, 2007
August 7, 2012
October 2005
November 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00432939 on ClinicalTrials.gov Archive Site
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Primary Hyperparathyroidism: Non-classical Manifestations
Primary Hyperparathyroidism: Non-classical Manifestations

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Specimens of frozen serum will be retained for possible future analyses.

Non-Probability Sample

Adults age 50 to 75 with Primary Hyperparathyroidism

Primary Hyperparathyroidism
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
58
December 2012
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

-Primary Hyperparathyroidism

Exclusion Criteria:

  • Current use of oral bisphosphonates
  • Addition or change in cholesterol lowering medication
  • impaired renal function (creatinine >2.0 mg/dl)
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00432939
AAAB1955, R01DK066329
Yes
Shonni J. Silverberg, Columbia University
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Shonni J Silverberg, MD Columbia University
Columbia University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP