NCT00961701

Brief Summary

Severe Primary hyperparathyroidism (PHP) has been associated with increased cardiovascular morbidity and mortality. Hypertension, dyslipidemia and impaired glucose tolerance were demonstrated in severe PHP, with improvement after surgery in these variables. Recent evidence suggests that the 'quality' rather than only the 'quantity' of low-density lipoprotein (LDL)-cholesterol exerts a direct influence on the cardiovascular risk. Thus, the proposed study protocol is intended to evaluate lipoprotein phenotype and LDL size and subclasses in patients with primary hyperparathyroidism.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

August 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

August 18, 2009

Last Update Submit

September 7, 2016

Conditions

Primary Hyperparathyroidism

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients followed at the Endocrine Institute

You may qualify if:

  • Patients with primary hyperparathyroidism

You may not qualify if:

  • pregnant women
  • patient taking hypolipidemic drugs
  • patients with known cardiovascular, peripheral or cerebral atherosclerotic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrine Institute , Haemek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Rafael Luboshitzky, MD

    Endocrine Institute, Haemek Medical Center, Afula, Israel

    STUDY DIRECTOR

  • Manfredi Rizzo, MD

    University of Palermo

    STUDY CHAIR

  • Giatgen Spinas, MD

    University of Zurich

    STUDY CHAIR

  • Kaspar Berneis, MD

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 19, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

IL(1)