- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006329
Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism
June 23, 2005 updated by: National Center for Research Resources (NCRR)
Parathyroid glands are small endocrine glands that secrete a hormone which controls blood calcium levels.
Primary hyperparathyroidism (PH) is a common disorder whereby one or more of these glands may enlarge and overproduce their hormone.
Subsequently, the elevated blood calcium can cause many other symptoms and problems.
The standard treatment is surgical removal of the gland(s) causing the disorder.
The standard safe and effective operation has been the bilateral open parathyroid exploration (BOPE).
A newer procedure using a radioactive compound that concentrates in the parathyroid glands allows a more limited operation to find and remove the causative gland [Minimally-Invasive Radioguided Parathyroidectomy (MIRP)].
The radiation exposure is minimal and safe.
Although the operation may prove to be less expensive, it is not certain whether it is as effective or as safe as BOPE.
This study serves to directly compare the costs, the effectiveness, and the safety associated with each type of operation.
All patients (adolescents and older) with PH are candidates to participate.
The participants will be randomly assigned to the MIRP group or the BOPE group independently of patient or physician preferences.
MIRP patients will undergo a sestamibi nuclear medicine scan to attempt to localize the specific parathyroid gland causing the hyperparathyroidism and subsequently a limited operation under local anesthesia to remove the single gland.
Parathyroid hormone levels will be measured during the operation to ensure that the patient has been cured.
If not, the standard BOPE procedure will be completed.
The total cost of the care will be tracked for each group.
Careful testing for complications such as vocal cord dysfunction will be done.
General Health status and pain levels will be measured before and after each operation.
Patient satisfaction with the operation and care will also be assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109-0331
- Univ. of Michigan Hosp, Dept. of Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Elevated serum calcium concentration on at least 2 occasions; if the value is <11.0 mg/dL, it must have been present for at least 6 months; if the serum albumin concentration is not normal, the ionized calcium level will be measured and must be elevated.
- Nephrolithiasis or documented bone mineral density less than 2.5 Standard Deviations below age matched means.
- Elevated or non-suppressed serum intact parathyroid hormone level
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 4, 2000
First Submitted That Met QC Criteria
October 4, 2000
First Posted (ESTIMATE)
October 5, 2000
Study Record Updates
Last Update Posted (ESTIMATE)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
November 1, 2001
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCRR-M01RR00042-1660
- M01RR000042 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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