Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial

Primary Hyperparathyroidism Clinical Trial

— SIPH  

Official title:

Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522028
• Other study ID #: S-96107 (REK)
• Secondary ID: 9571 (NSD)
• Status: Completed
• Phase: N/A
• First received: August 28, 2007
• Last updated: May 20, 2016
• Start date: October 1998
• Est. completion date: January 2016

Study information

• Verified date: June 1996
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Locations

Country	Name	City	State
Norway	Oslo University Hospital - Rikshospitalet	Oslo

Sponsors (8)

Lead Sponsor	Collaborator
Oslo University Hospital	Göteborg University, Haukeland University Hospital, Karolinska University Hospital, Rigshospitalet, Denmark, Rikshospitalet University Hospital, St. Olavs Hospital, Uppsala University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Bollerslev J, Jansson S, Mollerup CL, Nordenström J, Lundgren E, Tørring 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 hyperpa — View Citation

Bollerslev J, Rosen T, Mollerup CL, Nordenström J, Baranowski M, Franco C, Pernow Y, Isaksen GA, Godang K, Ueland T, Jansson S; SIPH Study Group. Effect of surgery on cardiovascular risk factors in mild primary hyperparathyroidism. J Clin Endocrinol Metab — View Citation

Lundstam K, Heck A, Mollerup C, Godang K, Baranowski M, Pernow Y, Varhaug JE, Hessman O, Rosén T, Nordenström J, Jansson S, Hellström M, Bollerslev J; SIPH Study Group. Effects of parathyroidectomy versus observation on the development of vertebral fractu — View Citation

Persson A, Bollerslev J, Rosen T, Mollerup CL, Franco C, Isaksen GA, Ueland T, Jansson S, Caidahl K; SIPH Study Group. Effect of surgery on cardiac structure and function in mild primary hyperparathyroidism. Clin Endocrinol (Oxf). 2011 Feb;74(2):174-80. d — View Citation