Skip to main content
OpenTrials
Completed

NCT Number: NCT00432939

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Metabolic Bone Diseases Unit

New York, 10032, United States

About this study

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.

  • Blood tests are performed at each visit. Approximately 1-2 tablespoons of blood will be drawn at each visit.
  • A 24-hour urine collection is done 3 times during the 2 year study.
  • Bone mineral density testing (known as DXA) is performed at baseline, 12 and 24 months after enrollment.
  • Carotid Ultrasound: At the baseline visit, 12 and 24 months after enrollment, carotid ultrasound is performed.
  • Echocardiogram: At the baseline visit, 12 and 24 months after enrollment, an echocardiogram is performed.
  • Endothelial Function: At baseline, 6 and 12 months after enrollment, flow mediated dilation of the brachial artery is performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT

    Time frame: 2 years

    To determine whether or not there is structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT as compared to matched healthy controls, and to determine the reversibility of these manifestations after successful parathyroidectomy

Secondary outcomes

  1. Evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT

    Time frame: 2 years

    To determine whether or not there is evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT, and to determine the reversibility of these manifestations after successful parathyroidectomy

  2. Evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery

    Time frame: 2 years

    To determine whether or not there is evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery, and to determine the reversibility of these manifestations after successful parathyroidectomy

Other outcomes

  1. To determine the association between the severity of PHPT and the presence of altered cardiovascular structure and function

    Time frame: 2 years

    To determine the association between the severity of PHPT and the presence of altered cardiovascular structure and function as assessed in outcomes 1 to 3

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2012
First posted
Feb 8, 2007
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.