An interventional study of parathyroidectomy and Observation in Hyperparathyroidism, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Not applicable, Interventional, and Treatment
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.
305 studies on the registry are indexed under Hyperparathyroidism; 23 are open to participants now.
This study's enrollment of 53 is close to the median of 58 across 203 interventional studies indexed under Hyperparathyroidism.
Browse Hyperparathyroidism studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Procedure: parathyroidectomy
Other: Observation
Standard parathyroidectomy with a bilateral approach
Usual care
Quality of Life
Change in 9 SF 36 scores
Time frame: 2 years
No study locations are listed for this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)