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Primary Hyperparathyroidism: Non-classical Manifestations

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes
  Purpose

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.


Condition
Primary Hyperparathyroidism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primary Hyperparathyroidism: Non-classical Manifestations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Biospecimen Retention:   Samples Without DNA

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


Enrollment: 58
Study Start Date: October 2005
Estimated Study Completion Date: December 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults age 50 to 75 with Primary Hyperparathyroidism

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432939

Locations
United States, New York
Metabolic Bone Diseases Unit
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Shonni J Silverberg, MD Columbia University
  More Information

No publications provided

Responsible Party: Shonni J. Silverberg, Professor of Medicine, Endocrinology, Columbia University
ClinicalTrials.gov Identifier: NCT00432939     History of Changes
Other Study ID Numbers: AAAB1955, R01DK066329
Study First Received: February 6, 2007
Last Updated: August 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
Primary Hyperparathyroidism

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013