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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Hyperparathyroidism
• Intervention / Treatment: Procedure: Parathyroid surgery

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 Type: Interventional
• Enrollment (Estimated): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Skåne University Hospital, Department of Surgery, Lund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 66 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration); Other Names: BA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density at the hip	Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.	At two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density at the lumbar spine	Bone density is assessed with DEXA (dual energy x-ray absorptiometry) at the lumber spine	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).	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).	At two years
Cognitive function	Mini Mental State Examination test (MMSE), for cognitive function. A Quich Test (AQT), for cognitive speed	At two years
Atherosclerosis	Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.	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.	At two years
Blood pressure (systolic and diastolic)	24 hours blood pressure measurement	At two years
Renal function	GFR measured by the clearance of iohexol and urinary albumin excretion	At two years

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Anders OJ Bergenfelz, MD, PhD, Skåne University Hospital, Department of Surgery, Lund

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2010
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 15, 2010
• First Submitted That Met QC Criteria: March 15, 2010
• First Posted (Estimated): March 16, 2010

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Atherosclerosis; Cognitive function; Follow-up; Osteoporosis; Randomized trial; Surgical Procedures, Elective; Indication; Hyperparathyroidism, primary; Aged 66 years or older; Mild hypercalcaemia
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism; Hyperparathyroidism, Primary; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Parathyroid Hormone
• Other Study ID Numbers: 2010/51