Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years Compared With Follow-up
Primary Purpose
Primary Hyperparathyroidism
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Parathyroid surgery
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hyperparathyroidism focused on measuring Hyperparathyroidism, primary, Aged 66 years or older, Mild hypercalcaemia, Surgical Procedures, Elective, Indication, Osteoporosis, Cognitive function, Atherosclerosis, Follow-up, Randomized trial
Eligibility Criteria
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
Sites / Locations
- Skåne University Hospital, Department of Surgery, Lund
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Follow-up
Surgery
Arm Description
Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only
Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery
Outcomes
Primary Outcome Measures
Bone density at the hip
Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.
Secondary Outcome Measures
Bone density at the lumbar spine
Bone density is assessed with DEXA (dual energy x-ray absorptiometry) at the lumber spine
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).
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).
Cognitive function
Mini Mental State Examination test (MMSE), for cognitive function.
A Quich Test (AQT), for cognitive speed
Atherosclerosis
Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.
Oral glucose tolerance
Oral glucose tolerance test (75 Gram), with measurement of blood glucose and insulin after 60, 120 and 180 min.
Blood pressure (systolic and diastolic)
24 hours blood pressure measurement
Renal function
GFR measured by the clearance of iohexol and urinary albumin excretion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01087619
Brief Title
Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years Compared With Follow-up
Official Title
Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2010 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism
Keywords
Hyperparathyroidism, primary, Aged 66 years or older, Mild hypercalcaemia, Surgical Procedures, Elective, Indication, Osteoporosis, Cognitive function, Atherosclerosis, Follow-up, Randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Follow-up
Arm Type
No Intervention
Arm Description
Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only
Arm Title
Surgery
Arm Type
Experimental
Arm Description
Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery
Intervention Type
Procedure
Intervention Name(s)
Parathyroid surgery
Other Intervention Name(s)
BA
Intervention Description
Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration)
Primary Outcome Measure Information:
Title
Bone density at the hip
Description
Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.
Time Frame
At two years
Secondary Outcome Measure Information:
Title
Bone density at the lumbar spine
Description
Bone density is assessed with DEXA (dual energy x-ray absorptiometry) at the lumber spine
Time Frame
At two years
Title
Blood lipids
Description
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
Title
Cardiac function
Description
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
Title
Cognitive function
Description
Mini Mental State Examination test (MMSE), for cognitive function.
A Quich Test (AQT), for cognitive speed
Time Frame
At two years
Title
Atherosclerosis
Description
Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.
Time Frame
At one two years
Title
Oral glucose tolerance
Description
Oral glucose tolerance test (75 Gram), with measurement of blood glucose and insulin after 60, 120 and 180 min.
Time Frame
At two years
Title
Blood pressure (systolic and diastolic)
Description
24 hours blood pressure measurement
Time Frame
At two years
Title
Renal function
Description
GFR measured by the clearance of iohexol and urinary albumin excretion
Time Frame
At two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders OJ Bergenfelz, MD, PhD
Organizational Affiliation
Skåne University Hospital, Department of Surgery, Lund
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital, Department of Surgery, Lund
City
Lund
ZIP/Postal Code
22185
Country
Sweden
12. IPD Sharing Statement
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Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years Compared With Follow-up
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