Primary HyperparathyroidismNCT00432939
Primary Hyperparathyroidism: Non-classical Manifestations
An observational study of Primary Hyperparathyroidism, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Primary Hyperparathyroidism
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults age 50 to 75 with Primary Hyperparathyroidism
Who may be able to join
- -Primary Hyperparathyroidism
Who cannot join
- Current use of oral bisphosphonates
- Addition or change in cholesterol lowering medication
- impaired renal function (creatinine >2.0 mg/dl)
Trial locations and contacts
1 site in 1 country.
United States1 site
Metabolic Bone Diseases Unit
New York, New York, 10032
About this study
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.
Read the 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.
- 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.
- Conditions
- Primary Hyperparathyroidism
- Keywords
- Primary Hyperparathyroidism
- Medical subject headings
- Hyperparathyroidism, Primary
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startOct 2005
- Primary completionNov 2009
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shonni J. Silverberg, Columbia University
- Investigators
- Shonni J Silverberg, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432939
- Sponsor's protocol ID
- AAAB1955
- Other IDs
- R01DK066329
- Status last verified
- Mar 2015
- First submitted
- 6 Feb 2007
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 33585500
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Hyperparathyroidism: Non-classical Manifestations
- ClinicalTrials.gov ID
- NCT00432939
- Acronym / sponsor ID
- AAAB1955
- Conditions
- Primary Hyperparathyroidism
- Keywords
- Primary Hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults age 50 to 75 with Primary Hyperparathyroidism
Key inclusion criteria (1 listed)
- -Primary Hyperparathyroidism
Key exclusion criteria (3 listed)
- Current use of oral bisphosphonates
- Addition or change in cholesterol lowering medication
- impaired renal function (creatinine >2.0 mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Evidence of abnormal cardiovascular function in patients with mild asymptomatic PHPT
Time frame: 2 years
Evidence of abnormal cardiovascular structure or function in patients with asymptomatic PHPT who meet NIH Guidelines for Surgery
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- Derived from this study: PubMed 33585500Camporese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shonni J Silverberg, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural evidence of increased vascular stiffness or cardiovascular calcification in patients with mild asymptomatic PHPT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015; AzTrials last refreshed its copy on 28 Oct 2026.