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

NCT01087619 | Completed

• 1 other identifier: 2010/51
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hyperparathyroidism

Keywords

Hyperparathyroidism, primary; Aged 66 years or older; Mild hypercalcaemia; Surgical Procedures, Elective; Indication; Osteoporosis; Cognitive function; Atherosclerosis; Follow-up; Randomized trial

Outcome Measures

Primary Outcomes (1)

• Bone density at the hip

  Bone density is assessed with DEXA (dual energy x-ray absorptiometry), at the hip.

  At two years

Secondary Outcomes (8)

• Bone density at the lumbar spine

  At two years

• Blood lipids

  At two years

• Cardiac function

  At two years

• Cognitive function

  At two years

• Atherosclerosis

  At one two years

Study Arms (2)

Follow-up

NO INTERVENTION

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

Surgery

EXPERIMENTAL

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

Procedure: Parathyroid surgery

Interventions

Parathyroid surgery PROCEDURE

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

Also known as: BA

Surgery

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Primary Hyperparathyroidism
• No previous parathyroid surgery
• Sporadic disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University Hospital, Department of Surgery, Lund

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Hyperparathyroidism, Primary; Osteoporosis; Atherosclerosis

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anders OJ Bergenfelz, MD, PhD

  Skåne University Hospital, Department of Surgery, Lund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2010
• First Posted: March 16, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2025
• Study Completion: February 28, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

SE (1)