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CompletedNCT01087619Updated Apr 8, 2026

Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years Compared With Follow-up

An interventional study of Parathyroid surgery in Primary Hyperparathyroidism, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 66 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Region Skane · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
66 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Primary Hyperparathyroidism

Keywords

  • Hyperparathyroidism, primary
  • Aged 66 years or older
  • Mild hypercalcaemia
  • Surgical Procedures, Elective
  • Indication
  • Osteoporosis
  • Cognitive function
  • Atherosclerosis
  • Follow-up
  • Randomized trial
03

In context

Hyperparathyroidism, Primary

104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.

This study's enrollment of 102 is above the median of 68 across 60 interventional studies indexed under Hyperparathyroidism, Primary.

Browse Hyperparathyroidism, Primary studies →

Lead sponsor

Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
66 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary Hyperparathyroidism
  • No previous parathyroid surgery
  • Sporadic disease

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • No intervention
    Follow-up

    Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only

  • Experimental
    Surgery

    Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery

    Procedure: Parathyroid surgery

Interventions

  • ProcedureParathyroid surgery

    Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration)

    Also known as: BA

06

What researchers measure

Primary outcomes

  1. Bone density at the hip

    Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.

    Time frame: At two years

Secondary outcomes

  1. Bone density at the lumbar spine

    Bone density is assessed with DEXA (dual energy x-ray absorptiometry) at the lumber spine

    Time frame: At two years

  2. 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).

    Time frame: At two years

  3. 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).

    Time frame: At two years

  4. Cognitive function

    Mini Mental State Examination test (MMSE), for cognitive function. A Quich Test (AQT), for cognitive speed

    Time frame: At two years

  5. Atherosclerosis

    Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.

    Time frame: At one two years

  6. Oral glucose tolerance

    Oral glucose tolerance test (75 Gram), with measurement of blood glucose and insulin after 60, 120 and 180 min.

    Time frame: At two years

  7. Blood pressure (systolic and diastolic)

    24 hours blood pressure measurement

    Time frame: At two years

  8. Renal function

    GFR measured by the clearance of iohexol and urinary albumin excretion

    Time frame: At two years

07

Study locations

1 site
  • Skåne University Hospital, Department of Surgery, Lund
    Lund, 22185, Sweden
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2010 to primary completion in Jun 2025, 178 months.

Of 20 interventional studies with no phase under Hyperparathyroidism, Primary, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 84. This study's 178 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2010
First posted
Mar 16, 2010
StartActual
Aug 2010
Primary completionActual
Jun 2025
CompletionActual
Feb 28, 2026
Last update
Apr 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01087619
Lead sponsor
Region Skane
Responsible party
Sponsor
First posted
Mar 16, 2010
Start date
Aug 2010
Primary completion
Jun 2025
Completion
Feb 28, 2026
Last update
Apr 8, 2026

Study contacts

Anders OJ Bergenfelz, MD, PhD
principal investigator · Skåne University Hospital, Department of Surgery, Lund

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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