A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism
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|ClinicalTrials.gov Identifier: NCT00004843|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : May 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperparathyroidism||Procedure: parathyroidectomy Other: Observation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic|
|Actual Study Start Date :||April 1997|
|Actual Primary Completion Date :||March 30, 1999|
|Actual Study Completion Date :||March 30, 1999|
Standard parathyroidectomy with a bilateral approach
|Active Comparator: Observation||
- Quality of Life [ Time Frame: 2 years ]Change in 9 SF 36 scores
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004843
|Study Chair:||D. Sudhaker Rao||Henry Ford Hospital|