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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rikshospitalet University Hospital
Göteborg University
Rigshospitalet, Denmark
Karolinska University Hospital
Uppsala University Hospital
Haukeland University Hospital
St. Olavs Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00522028
First received: August 28, 2007
Last updated: July 3, 2011
Last verified: June 1996
History of Changes

August 28, 2007
July 3, 2011
October 1998
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Complete list of historical versions of study NCT00522028 on ClinicalTrials.gov Archive Site
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Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial

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).

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Primary care clinic
Primary Hyperparathyroidism
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Bollerslev J, Jansson S, Mollerup CL, Nordenstrom J, Lundgren E, Torring O, Varhaug JE, Baranowski M, Aanderud S, Franco C, Freyschuss B, Isaksen GA, Ueland T, Rosen T. Medical observation, compared with parathyroidectomy, for asymptomatic primary hyperparathyroidism: a prospective, randomized trial. J Clin Endocrinol Metab. 2007 May;92(5):1687-92. Epub 2007 Feb 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
191
June 2015
Not Provided

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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00522028
S-96107 (REK), 9571 (NSD)
No
Rikshospitalet University Hospital, RRHF
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
Oslo University Hospital
June 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP