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CompletedNCT00004843Updated May 30, 2017

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

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

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Apr 1997, registered Feb 2000).
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Hyperparathyroidism

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Keywords

  • disease-related problem/condition
  • endocrine disorders
  • hyperparathyroidism
  • quality of life
  • rare disease
03

In context

Hyperparathyroidism

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Parathyroidectomy

    Procedure: parathyroidectomy

  • Active comparator
    Observation

    Other: Observation

Interventions

  • Procedureparathyroidectomy

    Standard parathyroidectomy with a bilateral approach

  • OtherObservation

    Usual care

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What researchers measure

Primary outcomes

  1. Quality of Life

    Change in 9 SF 36 scores

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Talpos GB, Bone HG 3rd, Kleerekoper M, Phillips ER, Alam M, Honasoge M, Divine GW, Rao DS. Randomized trial of parathyroidectomy in mild asymptomatic primary hyperparathyroidism: patient description and effects on the SF-36 health survey. Surgery. 2000 Dec;128(6):1013-20;discussion 1020-1. doi: 10.1067/msy.2000.110844. PubMed 11114637 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00004843
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Henry Ford Hospital
Responsible party
Sponsor
First posted
Feb 25, 2000
Start date
Apr 1997
Primary completion
Mar 30, 1999
Completion
Mar 30, 1999
Last update
May 30, 2017

Study contacts

D. Sudhaker Rao
study chair · Henry Ford Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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