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

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ClinicalTrials.gov Identifier: NCT00522028
Recruitment Status : Completed
First Posted : August 29, 2007
Last Update Posted : May 23, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease
Primary Hyperparathyroidism

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 Design

Study Type : Observational
Actual Enrollment : 191 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
Study Start Date : October 1998
Primary Completion Date : January 2016
Study Completion Date : January 2016

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522028

Oslo University Hospital - Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Rikshospitalet University Hospital
Göteborg University
Rigshospitalet, Denmark
Karolinska University Hospital
Uppsala University Hospital
Haukeland University Hospital
St. Olavs Hospital
Principal Investigator: Jens Bollerslev, MD Rikshospitalet University Hospital
More Information

Responsible Party: Jens Bollerslev, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00522028     History of Changes
Other Study ID Numbers: S-96107 (REK)
9571 (NSD) ( Other Identifier: Oslo University Hospital )
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: June 1996

Keywords provided by Jens Bollerslev, Oslo University Hospital:
Arterial pressure

Additional relevant MeSH terms:
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases