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Completed

NCT Number: NCT00522028

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).

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Key information

Conditions

Primary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Parathyroid Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital - Rikshospitalet

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

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

Registry information

Acronym: SIPH

Important dates

Study start
1998
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2007
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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