Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
NCT ID: NCT00522028
Last Updated: 2016-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
191 participants
OBSERVATIONAL
1998-10-31
2016-01-31
Brief Summary
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Detailed Description
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The patients will be followed up for 10 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 2.60\>S-Ca\<2.85 mmol/liter
* Age between 50 and 80 yr
* No medications interfering with Ca-metabolism
* Informed consent
Exclusion Criteria
* Previous operation in the neck
* Impaired kidney function
* Kidney stones
* Complicating medical conditions
* Psychiatric disorders
* Multiple endocrine neoplasia,
* Familial hypocalcuric hypercalcemia
* Familial HPT
50 Years
80 Years
ALL
No
Sponsors
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Rikshospitalet University Hospital
OTHER
Göteborg University
OTHER
Rigshospitalet, Denmark
OTHER
Karolinska University Hospital
OTHER
Uppsala University Hospital
OTHER
Haukeland University Hospital
OTHER
St. Olavs Hospital
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Jens Bollerslev
Professor
Principal Investigators
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Jens Bollerslev, MD
Role: PRINCIPAL_INVESTIGATOR
Rikshospitalet University Hospital
Locations
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Oslo University Hospital - Rikshospitalet
Oslo, Oslo County, Norway
Countries
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References
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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. doi: 10.1210/jc.2006-1836. Epub 2007 Feb 6.
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.
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.
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.
Heck A, Pretorius M, Lundstam K, Godang K, Hellstrom M, Ueland T, Bollerslev J. No effect of surgery on kidney and cardiovascular risk factors in mild primary hyperparathyroidism: secondary analyses from a 10-year randomized controlled trial. Eur J Endocrinol. 2024 Aug 30;191(3):354-360. doi: 10.1093/ejendo/lvae109.
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.
Other Identifiers
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9571 (NSD)
Identifier Type: OTHER
Identifier Source: secondary_id
S-96107 (REK)
Identifier Type: -
Identifier Source: org_study_id
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