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

NCT ID: NCT01087619

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2025-12-31

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.

Conditions

Primary Hyperparathyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Follow-up

Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are followed only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Surgery

Patients diagnosed biochemically and clinically with primary hyperparathyroidism who are treated with parathyroid surgery

Group Type: EXPERIMENTAL

Parathyroid surgery

Intervention Type: PROCEDURE

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

Interventions

Parathyroid surgery

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

Intervention Type: PROCEDURE

Other Intervention Names

BA

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

• Minimum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders OJ Bergenfelz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Skåne University Hospital, Department of Surgery, Lund

Locations

Skåne University Hospital, Department of Surgery, Lund

Lund, , Sweden

Countries

Sweden

Other Identifiers

2010/51

Identifier Type: -

Identifier Source: org_study_id