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

Primary Purpose

Hyperparathyroidism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
parathyroidectomy
Observation
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism focused on measuring disease-related problem/condition, endocrine disorders, hyperparathyroidism, quality of life, rare disease

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Parathyroidectomy

    Observation

    Arm Description

    Outcomes

    Primary Outcome Measures

    Quality of Life
    Change in 9 SF 36 scores

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    May 25, 2017
    Sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Collaborators
    Henry Ford Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004843
    Brief Title
    A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism
    Official Title
    A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1997 (Actual)
    Primary Completion Date
    March 30, 1999 (Actual)
    Study Completion Date
    March 30, 1999 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Collaborators
    Henry Ford Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperparathyroidism
    Keywords
    disease-related problem/condition, endocrine disorders, hyperparathyroidism, quality of life, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Parathyroidectomy
    Arm Type
    Experimental
    Arm Title
    Observation
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    parathyroidectomy
    Intervention Description
    Standard parathyroidectomy with a bilateral approach
    Intervention Type
    Other
    Intervention Name(s)
    Observation
    Intervention Description
    Usual care
    Primary Outcome Measure Information:
    Title
    Quality of Life
    Description
    Change in 9 SF 36 scores
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    D. Sudhaker Rao
    Organizational Affiliation
    Henry Ford Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11114637
    Citation
    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.
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    A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism

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