Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial (SIPH)

May 20, 2016 updated by: Jens Bollerslev, Oslo University Hospital
The present study is a randomized, controlled trial that investigates the effects of parathyroidectomy or medical observation in mild asymptomatic pHPT on morbidity and quality of life (QoL).

Study Overview

Status

Completed

Conditions

Detailed Description

The patients are included and randomized by block randomization to medical observation or parathyroidectomy by an experienced parathyroid surgeon.

The patients will be followed up for 10 years.

Study Type

Observational

Enrollment (Actual)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • Oslo University Hospital - Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Untreated, asymptomatic pHPT
  • 2.60>S-Ca<2.85 mmol/liter
  • Age between 50 and 80 yr
  • No medications interfering with Ca-metabolism
  • Informed consent

Exclusion Criteria:

  • Hyperparathyroid bone disease
  • Previous operation in the neck
  • Impaired kidney function
  • Kidney stones
  • Complicating medical conditions
  • Psychiatric disorders
  • Multiple endocrine neoplasia,
  • Familial hypocalcuric hypercalcemia
  • Familial HPT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Karolinska University Hospital
Göteborg University
Rigshospitalet, Denmark
Haukeland University Hospital
St. Olavs Hospital
Rikshospitalet University Hospital
Uppsala University Hospital

Investigators

  • Principal Investigator: Jens Bollerslev, MD, Rikshospitalet University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 28, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (Estimate)

August 29, 2007

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 20, 2016

Last Verified

June 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-96107 (REK)
  • 9571 (NSD) (Other Identifier: Oslo University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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