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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01087619
First received: March 15, 2010
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Primary Hyperparathyroidism
Procedure: Parathyroid surgery

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 160
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)
Arms Assigned Interventions
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 Name: BA

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.

  Eligibility

Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087619

Contacts
Contact: Anders OJ Bergenfelz, MD, PhD +46 46 172086 anders.bergenfelz@med.lu.se
Contact: Erik Nordenström, MD, PhD +46 46 172305 erik.nordenstrom@skane.se

Locations
Sweden
Skåne University Hospital, Department of Surgery, Lund Recruiting
Lund, Sweden, 22185
Contact: Anders OJ Bergenfelz, MD, PhD    +46 46 17 20 86    anders.bergenfelz@med.lu.se   
Contact: Erik Nordenström, MD, PhD    +46 46 17 23 05    erik.nordenstrom@skane.se   
Sub-Investigator: Erik Nordenström, MD, PhD         
Sub-Investigator: Martin Almqvist, MD, PhD         
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Anders OJ Bergenfelz, MD, PhD Skåne University Hospital, Department of Surgery, Lund
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01087619     History of Changes
Other Study ID Numbers: 2010/51
Study First Received: March 15, 2010
Last Updated: July 5, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Hyperparathyroidism, primary
Aged 66 years or older
Mild hypercalcaemia
Surgical Procedures, Elective
Indication
Osteoporosis
Cognitive function
Atherosclerosis
Follow-up
Randomized trial

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014