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.

Study Overview

• Status: Completed
• Conditions: Primary Hyperparathyroidism

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.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Metabolic Bone Diseases Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults age 50 to 75 with Primary Hyperparathyroidism

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Shonni J Silverberg, MD, Columbia University

Publications and helpful links

General Publications

• Camporese G, Bernardi E, Bortoluzzi C, Noventa F, Hong NV, Callegari E, Villalta S, Tonello C, Nardin M, Campello E, Spiezia L, Simioni P. MAC Project-Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol. Front Med (Lausanne). 2021 Jan 28;7:584459. doi: 10.3389/fmed.2020.584459. eCollection 2020.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 6, 2007
• First Submitted That Met QC Criteria: February 6, 2007
• First Posted (Estimate): February 8, 2007

Study Record Updates

• Last Update Posted (Estimate): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Primary Hyperparathyroidism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary
• Other Study ID Numbers: AAAB1955; R01DK066329 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No