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

Region Skane

Status: Active, not recruiting

Conditions: Primary Hyperparathyroidism

Treatments: Procedure: Parathyroid surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01087619

2010/51

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 estimated patients

Sex: All

Ages: 66+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Follow-up

No Intervention group

Description:

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

Surgery

Experimental group

Description:

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

Treatment:

Procedure: Parathyroid surgery