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

This study has been completed.
Sponsor:
Collaborators:
Rikshospitalet University Hospital
Göteborg University
Rigshospitalet, Denmark
Karolinska University Hospital
Uppsala University Hospital
Haukeland University Hospital
St. Olavs Hospital
Information provided by (Responsible Party):
Jens Bollerslev, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00522028
First received: August 28, 2007
Last updated: May 20, 2016
Last verified: June 1996
  Purpose
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
Primary Hyperparathyroidism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Enrollment: 191
Study Start Date: October 1998
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522028

Locations
Norway
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
Investigators
Principal Investigator: Jens Bollerslev, MD Rikshospitalet University Hospital
  More Information

Publications:
Responsible Party: Jens Bollerslev, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00522028     History of Changes
Other Study ID Numbers: S-96107 (REK)  9571 (NSD) 
Study First Received: August 28, 2007
Last Updated: May 20, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Oslo University Hospital:
QoL
Osteodensitometry
Arterial pressure
PTH

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

ClinicalTrials.gov processed this record on December 06, 2016