Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial

NCT ID: NCT00522028

Last Updated: 2016-05-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

191 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-10-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Primary Hyperparathyroidism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rikshospitalet University Hospital

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jens Bollerslev

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Norway

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.

Reference Type RESULT
PMID: 17284629 (View on PubMed)

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.

Reference Type RESULT
PMID: 19351725 (View on PubMed)

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.

Reference Type RESULT
PMID: 21044114 (View on PubMed)

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.

Reference Type RESULT
PMID: 25636048 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39189547 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35436153 (View on PubMed)

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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