Primary Hyperparathyroidism: Non-classical Manifestations
2 other identifiers
observational
58
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 6, 2007
CompletedFirst Posted
Study publicly available on registry
February 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMarch 9, 2015
March 1, 2015
4.1 years
February 6, 2007
March 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT
2 years
Evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery
2 years
Other Outcomes (1)
To determine the association between the severity of PHPT and the presence of altered cardiovascular structure and function
2 years
Eligibility Criteria
Adults age 50 to 75 with Primary Hyperparathyroidism
You may qualify if:
- Primary Hyperparathyroidism
You may not qualify if:
- Current use of oral bisphosphonates
- Addition or change in cholesterol lowering medication
- impaired renal function (creatinine \>2.0 mg/dl)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Metabolic Bone Diseases Unit
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 33585500DERIVED
Biospecimen
Specimens of frozen serum will be retained for possible future analyses.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shonni J Silverberg, MD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Endocrinology
Study Record Dates
First Submitted
February 6, 2007
First Posted
February 8, 2007
Study Start
October 1, 2005
Primary Completion
November 1, 2009
Study Completion
December 1, 2012
Last Updated
March 9, 2015
Record last verified: 2015-03