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

Primary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01087619
• Other study ID #: 2010/51
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2010
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Intervention

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

Locations

Country	Name	City	State
Sweden	Skåne University Hospital, Department of Surgery, Lund	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

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