Clinical trial NCT00522028: Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
Official title: Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hyperparathyroidism
Keywords: QoL
Osteodensitometry
Arterial pressure
PTH
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Rikshospitalet University Hospital
name: Göteborg University
name: Rigshospitalet, Denmark
name: Karolinska University Hospital
name: Uppsala University Hospital
name: Haukeland University Hospital
name: St. Olavs Hospital
First posted: 2007-08-29
Enrollment: 191
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

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).

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital - Rikshospitalet
Study officials:
affiliation: Rikshospitalet University Hospital
name: Jens Bollerslev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1210/jc.2006-1836. Epub 2007 Feb 6.
citation: Bollerslev J, Rosen T, Mollerup CL, Nordenstrom 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. 2009 Jul;94(7):2255-61. doi: 10.1210/jc.2008-2742. Epub 2009 Apr 7.
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. doi: 10.1111/j.1365-2265.2010.03909.x.
citation: Lundstam K, Heck A, Mollerup C, Godang K, Baranowski M, Pernow Y, Varhaug JE, Hessman O, Rosen T, Nordenstrom J, Jansson S, Hellstrom M, Bollerslev J; SIPH Study Group. Effects of parathyroidectomy versus observation on the development of vertebral fractures in mild primary hyperparathyroidism. J Clin Endocrinol Metab. 2015 Apr;100(4):1359-67. doi: 10.1210/jc.2014-3441. Epub 2015 Jan 30.
citation: Pretorius M, Lundstam K, Heck A, Fagerland MW, Godang K, Mollerup C, Fougner SL, Pernow Y, Aas T, Hessman O, Rosen T, Nordenstrom J, Jansson S, Hellstrom M, Bollerslev J. Mortality and Morbidity in Mild Primary Hyperparathyroidism: Results From a 10-Year Prospective Randomized Controlled Trial of Parathyroidectomy Versus Observation. Ann Intern Med. 2022 Jun;175(6):812-819. doi: 10.7326/M21-4416. Epub 2022 Apr 19.