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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 1998 by Office of Rare Diseases (ORD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Henry Ford Hospital
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004843
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 1998

February 24, 2000
June 23, 2005
June 1994
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Complete list of historical versions of study NCT00004843 on ClinicalTrials.gov Archive Site
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A Randomized Study of Surgery Vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism
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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.

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.

Interventional
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Allocation: Randomized
Primary Purpose: Treatment
Hyperparathyroidism
Procedure: parathyroidectomy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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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

Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004843
199/13926, HFH-5R01DK43858
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Henry Ford Hospital
Study Chair: D. Sudhaker Rao Henry Ford Hospital
Office of Rare Diseases (ORD)
December 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP