NCT00004843

A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism

A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Assess the efficacy of surgery vs no surgery in patients with mild asymptomatic primary hyperparathyroidism. II. Assess the quality of life, morbidity, and mortality of these patients.

Detailed description

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by gender. Patients are randomized to receive surgery or follow up without surgery. Patients receive parathyroidectomy (current standard care) or long term follow up without parathyroidectomy. Quality of life is assessed before the study and then every 6 months. All patients are followed every 6 months until death.

Conditions

• Hyperparathyroidism

Interventions

Type	Name	Description
PROCEDURE	parathyroidectomy	Standard parathyroidectomy with a bilateral approach
OTHER	Observation	Usual care

Timeline

• Start date: 1997-04-01
• Primary completion: 1999-03-30
• Completion: 1999-03-30
• First posted: 2000-02-25
• Last updated: 2017-05-30