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 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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up|
- Bone density [ Time Frame: At one and two years ] [ Designated as safety issue: No ]Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the lumbar spine and hip.
- Blood lipids [ Time Frame: At one and two years ] [ Designated as safety issue: No ]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 [ Time Frame: At one and two years ] [ Designated as safety issue: No ]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 [ Time Frame: At one and two years ] [ Designated as safety issue: No ]
Mini Mental State Examination test (MMSE), for cognitive function.
A Quich Test (AQT), for cognitive speed
- Atherosclerosis [ Time Frame: At one and two years ] [ Designated as safety issue: No ]Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.
- Oral glucose tolerance [ Time Frame: At one and two years ] [ Designated as safety issue: No ]Oral glucose tolerance test (75 Gram), with measurement of blood glucose and insulin after 60, 120 and 180 min.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
No Intervention: Follow-up
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
Procedure: Parathyroid surgery
Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration)
Other Name: BA
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087619
|Contact: Anders OJ Bergenfelz, MD, PhD||+46 46 firstname.lastname@example.org|
|Contact: Erik Nordenström, MD, PhD||+46 46 email@example.com|
|Skåne University Hospital, Department of Surgery, Lund||Recruiting|
|Lund, Sweden, 22185|
|Contact: Anders OJ Bergenfelz, MD, PhD +46 46 17 20 86 firstname.lastname@example.org|
|Contact: Erik Nordenström, MD, PhD +46 46 17 23 05 email@example.com|
|Sub-Investigator: Erik Nordenström, MD, PhD|
|Sub-Investigator: Martin Almqvist, MD, PhD|
|Principal Investigator:||Anders OJ Bergenfelz, MD, PhD||Skåne University Hospital, Department of Surgery, Lund|