HyperparathyroidismNCT00004843
A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic Primary Hyperparathyroidism
A study testing parathyroidectomy and Observation in people with Hyperparathyroidism, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial 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 more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hyperparathyroidism
- What is being tested?
- parathyroidectomy and Observation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Apr 1997to 30 Mar 1999
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic
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.
- Conditions
- Hyperparathyroidism
- Being tested
- parathyroidectomy, Observation
- Keywords
- disease-related problem/condition, endocrine disorders, hyperparathyroidism, quality of life, rare disease
- Medical subject headings
- Hyperparathyroidism, Endocrine System Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroidectomyProcedure or surgery
Standard parathyroidectomy with a bilateral approach
ObservationOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Parathyroidectomy | Experimental | Not described Receives: Procedure: parathyroidectomy |
| Observation | Active comparator | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Change in 9 SF 36 scores
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startApr 1997
- Primary completion30 Mar 1999
- Study completion30 Mar 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Henry Ford Hospital
- Responsible party
- Sponsor
- Investigators
- D. Sudhaker Rao, Study chair, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004843
- Sponsor's protocol ID
- 199/13926
- Other IDs
- R01DK043858
- Status last verified
- May 2017
- First submitted
- 24 Feb 2000
- Last updated
- 30 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Surgery vs No Surgery in Patients With Mild Asymptomatic
- ClinicalTrials.gov ID
- NCT00004843
- Acronym / sponsor ID
- 199/13926
- Conditions
- Hyperparathyroidism
- Keywords
- disease-related problem/condition, endocrine disorders, hyperparathyroidism, quality of life, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Henry Ford Hospital
- Study start
- Apr 1997 (actual)
- Primary completion
- 30 Mar 1999 (actual)
- Study completion
- 30 Mar 1999 (actual)
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parathyroidectomy | Experimental | Procedure: parathyroidectomy |
| Observation | Active comparator | Other: Observation |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parathyroidectomyStandard parathyroidectomy with a bilateral approach | Procedure or surgery | Parathyroidectomy |
| ObservationUsual care | Other | Observation |
Primary outcome
Quality of Life
Time frame: 2 years
Change in 9 SF 36 scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Results publication: PubMed 11114637Talpos 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.
Related trials for Hyperparathyroidism
RecruitingObservational study
Natural History Study of Parathyroid Disorders
Parathyroid Cancer, Primary Hyperparathyroidism
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruiting
Treating PHPT With the nPulse™ Vybrance™ PE System
Primary Hyperparathyroidism
RecruitingEarly Phase 1
Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas
Hyperparathyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D. Sudhaker Rao study chair
Henry Ford Hospital
Questions about this trial
What is this clinical trial studying?
A study testing parathyroidectomy and Observation in people with Hyperparathyroidism, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.