Primary HyperparathyroidismSIPHNCT00522028
Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
An observational study of Primary Hyperparathyroidism, run by Oslo University Hospital at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Primary Hyperparathyroidism
- How many people
- 191 participants
- Where
- 1 siteNorway
- Study dates
- Oct 1998to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- Hyperparathyroid bone disease
- Previous operation in the neck
- Impaired kidney function
- Kidney stones
- Complicating medical conditions
- Psychiatric disorders
Show all 9Show fewer
- Multiple endocrine neoplasia,
- Familial hypocalcuric hypercalcemia
- Familial HPT
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Primary Hyperparathyroidism
- Keywords
- QoL, Osteodensitometry, Arterial pressure, PTH
- Medical subject headings
- Hyperparathyroidism, Primary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startOct 1998
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rikshospitalet University Hospital, Göteborg University, Copenhagen University Hospital, Rigshospitalet, Karolinska University Hospital, Uppsala University Hospital, Haukeland University Hospital, St. Olavs Hospital
- Responsible party
- Principal investigator, Jens Bollerslev, Oslo University Hospital
- Investigators
- Jens Bollerslev, MD, Principal investigator, Rikshospitalet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522028
- Sponsor's protocol ID
- S-96107 (REK)
- Other IDs
- 9571 (NSD)
- Acronym
- SIPH
- Status last verified
- Jun 1996
- First submitted
- 28 Aug 2007
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17284629Bollerslev 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.
PubMed 19351725Persson 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.
PubMed 21044114Lundstam 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.
PubMed 25636048Heck 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.
PubMed 39189547Pretorius 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.
PubMed 35436153
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT00522028
- Acronym / sponsor ID
- SIPH / S-96107 (REK)
- Conditions
- Primary Hyperparathyroidism
- Keywords
- QoL, Osteodensitometry, Arterial pressure, PTH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Rikshospitalet University Hospital, Göteborg University, Copenhagen University Hospital, Rigshospitalet, Karolinska University Hospital, Uppsala University Hospital, Haukeland University Hospital, St. Olavs Hospital
- Study start
- Oct 1998
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Hyperparathyroid bone disease
- Previous operation in the neck
- Impaired kidney function
- Kidney stones
- Complicating medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Results publication: PubMed 17284629Bollerslev 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.
- Results publication: PubMed 19351725Bollerslev 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.
- Results publication: PubMed 21044114Persson 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.
- Results publication: PubMed 25636048Lundstam 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.
- Derived from this study: PubMed 39189547Heck 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.
- Derived from this study: PubMed 35436153Pretorius 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Bollerslev, MD principal investigator
Rikshospitalet University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hyperparathyroidism, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00522028, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.