Primary HyperparathyroidismNCT01087619
Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years Compared With Follow-up
A study testing Parathyroid surgery in people with Primary Hyperparathyroidism, run by Region Skane at 1 site in Sweden.
Trial summary
General consensus and contemporary guidelines, recommend surgery for primary hyperparathyroidism (pHPT)for all patients below the age of 50, for patients with pronounced hypercalcemia and for patients with organ complications to the disease (osteoporosis and decreased renal function). Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- Parathyroid surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2010to 28 Feb 2026
- Phase
- Interventional
- 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 66 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Primary Hyperparathyroidism
- No previous parathyroid surgery
- Sporadic disease
Who cannot join
- Z-score of Bone density < -2.5 SD (regardless of site)
- Serum level of ionized calcium > 1.50 mmol/L
- Inability to understand given information or to comply with scheduled follow-up
- Symptoms of hypercalcaemia for which specific medical treatment has been prescribed
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Skåne University Hospital, Department of Surgery, Lund
Lund, 22185
About this study
Official title: Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up
General consensus and contemporary guidelines, recommend surgery for primary hyperparathyroidism (pHPT)for all patients below the age of 50, for patients with pronounced hypercalcemia and for patients with organ complications to the disease (osteoporosis and decreased renal function).
The purpose of this study is to determine if surgery for pHPT, is appropriate for patients with moderate to mild hypercalcemia older than 65 years of age.
The hypothesis of the study is that surgery for pHPT in patients older than 65 years of age, and with mild hypercalcemia, will increase bone density and hence decrease future risk for fragility fractures compared to patients with follow-up only.
Read the detailed description
The majority of patients diagnosed and operated due to primary HPT in Scandinavia are older than 65 years of age. The vast majority of the patients have mild aberrations of serum calcium (< 1.50 mmol/l ionized calcium), and some patients may even be asymptomatic. The present trial is designed to clarify the indications for surgical treatment in this large subgroup of patients.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- Parathyroid surgery
- Keywords
- Hyperparathyroidism, primary, Aged 66 years or older, Mild hypercalcaemia, Surgical Procedures, Elective, Indication, Osteoporosis, Cognitive function, Atherosclerosis, Follow-up, Randomized trial
- Medical subject headings
- Hyperparathyroidism, Primary, Osteoporosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parathyroid surgeryProcedure or surgery
Also called BA
Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration)
| Study group | Role | What they receive |
|---|---|---|
| Follow-up | No intervention | Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only |
| Surgery | Experimental | Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery Receives: Procedure: Parathyroid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density at the hip
Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.
Measured: At two years
Secondary outcomes (8)
Bone density at the lumbar spine
Bone density is assessed with DEXA (dual energy x-ray absorptiometry) at the lumber spine
Measured: At two years
Blood lipids
Triglyceride and cholesterol concentrations of whole serum and of the lipoprotein classes; low-density-lipoprotein (LDL), very-low-density-lipoprotein (VLDL) and high-density-lipoprotein (HDL).
Measured: At two years
Cardiac function
Cardiac function assessed with echocardiography; Left ventricular ejection fraction (EF), Left ventricular end-diastolic diameter (LVDD), Left ventricular mass index (LVMI), Ratio between mitral peak velocity flow of the early filling wave and the atrial filling wave (E/A ratio).
Measured: At two years
Cognitive function
Mini Mental State Examination test (MMSE), for cognitive function.
A Quich Test (AQT), for cognitive speed
Measured: At two years
Atherosclerosis
Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.
Measured: At one two years
Oral glucose tolerance
Oral glucose tolerance test (75 Gram), with measurement of blood glucose and insulin after 60, 120 and 180 min.
Measured: At two years
Blood pressure (systolic and diastolic)
24 hours blood pressure measurement
Measured: At two years
Renal function
GFR measured by the clearance of iohexol and urinary albumin excretion
Measured: At two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Region SkaneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders OJ Bergenfelz, MD, PhD, Principal investigator, Skåne University Hospital, Department of Surgery, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087619
- Sponsor's protocol ID
- 2010/51
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2010
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergenfelz AOJ, Thier M, Almquist M, Ranstam JP, Nordenstrom ED. Surgery versus observation in patients 65 years or older with primary hyperparathyroidism: randomized clinical trial. BJS Open. 2026 Sep 4;10(5):zrag151. doi: 10.1093/bjsopen/zrag151.
PubMed 42817602
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up
- ClinicalTrials.gov ID
- NCT01087619
- Acronym / sponsor ID
- 2010/51
- Conditions
- Primary Hyperparathyroidism
- Keywords
- Hyperparathyroidism, primary, Aged 66 years or older, Mild hypercalcaemia, Surgical Procedures, Elective, Indication, Osteoporosis, Cognitive function, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- Jun 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 16 Mar 2010 (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.
General consensus and contemporary guidelines, recommend surgery for primary hyperparathyroidism (pHPT)for all patients below the age of 50, for patients with pronounced hypercalcemia and for patients with organ complications to the disease (osteoporosis and decreased renal function).
The purpose of this study is to determine if surgery for pHPT, is appropriate for patients with moderate to mild hypercalcemia older than 65 years of age.
The hypothesis of the study is that surgery for pHPT in patients older than 65 years of age, and with mild hypercalcemia, will increase bone density and hence decrease future risk for fragility fractures compared to patients with follow-up only.
Detailed description
The majority of patients diagnosed and operated due to primary HPT in Scandinavia are older than 65 years of age. The vast majority of the patients have mild aberrations of serum calcium (< 1.50 mmol/l ionized calcium), and some patients may even be asymptomatic. The present trial is designed to clarify the indications for surgical treatment in this large subgroup of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up | No intervention | –Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only |
| Surgery | Experimental | Procedure: Parathyroid surgeryPatients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Primary Hyperparathyroidism
- No previous parathyroid surgery
- Sporadic disease
Key exclusion criteria (4 listed)
- Z-score of Bone density < -2.5 SD (regardless of site)
- Serum level of ionized calcium > 1.50 mmol/L
- Inability to understand given information or to comply with scheduled follow-up
- Symptoms of hypercalcaemia for which specific medical treatment has been prescribed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parathyroid surgeryAlso: BAParathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration) | Procedure or surgery | Surgery |
Primary outcome
Bone density at the hip
Time frame: At two years
Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.
8 secondary outcomes
Bone density at the lumbar spine
Time frame: At two years
Blood lipids
Time frame: At two years
Cardiac function
Time frame: At two years
Cognitive function
Time frame: At two years
Atherosclerosis
Time frame: At one two years
Oral glucose tolerance
Time frame: At two years
Blood pressure (systolic and diastolic)
Time frame: At two years
Renal function
Time frame: At two years
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 8 Apr 2026.
- Derived from this study: PubMed 42817602Bergenfelz AOJ, Thier M, Almquist M, Ranstam JP, Nordenstrom ED. Surgery versus observation in patients 65 years or older with primary hyperparathyroidism: randomized clinical trial. BJS Open. 2026 Sep 4;10(5):zrag151. doi: 10.1093/bjsopen/zrag151.
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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.
Anders OJ Bergenfelz, MD, PhD principal investigator
Skåne University Hospital, Department of Surgery, Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parathyroid surgery in people with Primary Hyperparathyroidism, run by Region Skane at 1 site in Sweden.
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 3 inclusion and 4 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 8 Apr 2026. 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 Sweden. 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.
What does the primary outcome measure?
Bone density at the hip (time frame: At two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01087619, which also lists 1 linked publication.
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 8 Apr 2026.