A Randomized Study of Surgery Vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism
This trial is active, not recruiting.
|Sponsor||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Collaborator||Henry Ford Hospital|
|Start date||June 1994|
|Trial size||100 participants|
|Trial identifier||NCT00004843, 199/13926, HFH-5R01DK43858|
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.
Male or female participants from 50 years up to 75 years old.
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically diagnosed mild asymptomatic primary hyperparathyroidism Persistent albumin adjusted serum calcium between 10.1-11.5 mg/dL for at least 3 months Intact parathyroid hormone greater than 20 pg/mL No other cause for hypercalcemia No family history of primary hyperparathyroidism, primary endocrine neoplasia, or hypocalciuric hypercalcemia Bone mineral density of the forearm no greater than 2.0 SD units below the expected value for sex, age, and race No phalangeal subperiosteal resorption on hand x-rays --Prior/Concurrent Therapy-- Radiotherapy: No history of childhood irradiation to head and neck Surgery: No thyroid disease requiring surgical intervention Other: No prior glucocorticoid or anticonvulsant drug therapy Concurrent thiazide diuretic therapy for hypertension must be changed to nonthiazides --Patient Characteristics-- Menopausal status: At least 5 years postmenopausal Renal: At least 2 years since prior nephrolithiasis Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 70% (age adjusted) Cardiovascular: No unexpected finding on echocardiogram that will interfere with surgical intervention Other: Living within 150 mile radius of downtown Detroit No concurrent participation in other clinical trials No concurrent polyuria, polydipsia, anorexia, nausea, or vomiting At least 12 months since prior pancreatitis No concurrent symptomatic peptic ulcer disease No objective muscle weakness No history of nontraumatic vertebral or hip fractures No vertebral compression fractures No urolithiasis on x-ray of abdomen
|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.|
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