Surgery for Primary Hyperparathyroidism (pHPT) in Patients Older Than 65 Years Compared With Follow-up
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01087619|
Recruitment Status : Recruiting
First Posted : March 16, 2010
Last Update Posted : December 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Hyperparathyroidism||Procedure: Parathyroid surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up|
|Actual Study Start Date :||August 2010|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||June 2022|
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
- Bone density at the hip [ Time Frame: At two years ]Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.
- 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
- 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).
- 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).
- Cognitive function [ Time Frame: At two years ]
Mini Mental State Examination test (MMSE), for cognitive function.
A Quich Test (AQT), for cognitive speed
- Atherosclerosis [ Time Frame: At one two years ]Carotid ultrasound/duplex scans with evaluation of intimal-medial thickness and plaques.
- 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.
- Blood pressure (systolic and diastolic) [ Time Frame: At two years ]24 hours blood pressure measurement
- Renal function [ Time Frame: At two years ]GFR measured by the clearance of iohexol and urinary albumin excretion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087619
|Contact: Anders OJ Bergenfelz, MD, PhD||+46 46 email@example.com|
|Contact: Erik Nordenström, MD, PhD||+46 46 firstname.lastname@example.org|
|Skåne University Hospital, Department of Surgery, Lund||Recruiting|
|Lund, Sweden, 22185|
|Contact: Anders OJ Bergenfelz, MD, PhD +46 46 17 20 86 email@example.com|
|Contact: Erik Nordenström, MD, PhD +46 46 17 23 05 firstname.lastname@example.org|
|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|