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NCT Number: NCT01087619

Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years 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.

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Key information

Conditions

Primary Hyperparathyroidism Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Bone Diseases Bone Diseases, Metabolic Cardiovascular Diseases Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Primary Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Parathyroid Diseases Vascular Diseases

Age range

66 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University Hospital, Department of Surgery, Lund

Lund, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary Hyperparathyroidism
  • No previous parathyroid surgery
  • Sporadic disease

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

Treatment and study plan

Parathyroid Surgery

Procedure

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

Other names: BA

Primary outcomes

  1. Bone density at the hip

    Time frame: At two years

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

Secondary outcomes

  1. Bone density at the lumbar spine

    Time frame: At two years

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

  2. Blood lipids

    Time frame: At two years

    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).

  3. Cardiac function

    Time frame: At two years

    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).

  4. Cognitive function

    Time frame: At two years

    Mini Mental State Examination test (MMSE), for cognitive function.

    A Quich Test (AQT), for cognitive speed

  5. Atherosclerosis

    Time frame: At one two years

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

  6. Oral glucose tolerance

    Time frame: At two years

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

  7. Blood pressure (systolic and diastolic)

    Time frame: At two years

    24 hours blood pressure measurement

  8. Renal function

    Time frame: At two years

    GFR measured by the clearance of iohexol and urinary albumin excretion

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up

Important dates

Study start
2010
Primary completion
2025
Study completion
2026
First posted
Mar 16, 2010
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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