Clinical Trials Directory

Trials / Completed

CompletedNCT01087619

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

Primary Hyperparathyroidism in Patients Older Than 65 Years: A Prospective Randomized Trial of Surgical Treatment Compared With Follow-up

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Region Skane · Academic / Other
Sex
All
Age
66 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2010-08-01
Primary completion
2025-06-01
Completion
2026-02-28
First posted
2010-03-16
Last updated
2026-04-08

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01087619. Inclusion in this directory is not an endorsement.