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

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Overall Status

Completed

CT.gov ID

NCT00004843

Collaborator

Henry Ford Hospital (Other)

Enrollment

Arms

23.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Assess the efficacy of surgery vs no surgery in patients with mild asymptomatic primary hyperparathyroidism.

Assess the quality of life, morbidity, and mortality of these patients.

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism	Procedure: parathyroidectomy Other: Observation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 1997

Actual Primary Completion Date :

Mar 30, 1999

Actual Study Completion Date :

Mar 30, 1999

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parathyroidectomy	Procedure: parathyroidectomy Standard parathyroidectomy with a bilateral approach
Active Comparator: Observation	Other: Observation Usual care

Arm

Intervention/Treatment

Experimental: Parathyroidectomy

Procedure: parathyroidectomy

Standard parathyroidectomy with a bilateral approach

Active Comparator: Observation

Other: Observation

Usual care

Outcome Measures

Primary Outcome Measures

Quality of Life [2 years]
Change in 9 SF 36 scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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