A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic|
- Quality of Life [ Time Frame: 2 years ]Change in 9 SF 36 scores
|Actual Study Start Date:||April 1997|
|Study Completion Date:||March 30, 1999|
|Primary Completion Date:||March 30, 1999 (Final data collection date for primary outcome measure)|
Standard parathyroidectomy with a bilateral approach
|Active Comparator: Observation||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004843
|Study Chair:||D. Sudhaker Rao||Henry Ford Hospital|