Primary Hyperparathyroidism: Non-classical Manifestations

Primary Hyperparathyroidism Clinical Trial

Official title:

Primary Hyperparathyroidism: Non-classical Manifestations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432939
• Other study ID #: AAAB1955
• Secondary ID: R01DK066329
• Status: Completed
• Phase: N/A
• First received: February 6, 2007
• Last updated: March 6, 2015
• Start date: October 2005
• Est. completion date: December 2012

Study information

• Verified date: March 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2012
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Locations

Country	Name	City	State
United States	Metabolic Bone Diseases Unit	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To determine the association between the severity of PHPT and the presence of altered cardiovascular structure and function	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	2 years	No
Primary	Structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT	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	2 years	No
Secondary	Evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT	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 years	No
Secondary	Evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery	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	2 years	No