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Coexisting Thyroid Disease and Hyperparathyroidism

Coexisting Thyroid Disease and Hyperparathyroidism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01306916
Enrollment
30
Registered
2011-03-02
Start date
2004-09-30
Completion date
2012-07-31
Last updated
2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperthyroidism

Keywords

thyroid disease, hyperthyroidism

Brief summary

Purpose: Prospective studies of patients with hyperparathyroidism are warranted to determine the prevalence of concurrent thyroid disease applying the current standard of pre-operative radioscintigraphic and sonographic imaging of the neck. Timely diagnosis and treatment of co-existing thyroid disease is advantageous given the well-established increased morbidity associated with a second neck exploration. The purpose of this study is to determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism, and to determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism. Research Design: This will be a prospective single arm observational study of up to 200 military health care beneficiaries over the age of 18 years with primary and secondary hyperparathyroidism scheduled to undergo parathyroid resection. Methodology: Patients will undergo standard pre-operative imaging of the neck including ultrasonography and 99mTc-sestamibi scintigraphy. An operative plan will be developed based on the information obtained from history, physical examination, laboratory studies, and imaging studies. The number and type of thyroid disease in these patients will be determined based on these non-invasive studies (Objective A). A change in the otherwise standard treatment will include those patients having partial or complete resections of their thyroid glands because: a) the patients would have undergone minimally invasive surgery if not for the results of the imaging studies, and, b) the patients who would have undergone 3 ½ gland parathyroidectomy if not for the results of the imaging studies (Objective B).

Interventions

None listed

Sponsors

Walter Reed Army Medical Center
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with hyperparathyroidism and appropriate indications for operation * Patients over 18 years of age and capable of providing informed consent * Each patient must provide written informed consent prior to entering the study.

Exclusion criteria

* Patients who have previously undergone thyroid or parathyroid operation * Patients with medullary thyroid carcinoma and hyperparathyroidism or suspected multiple endocrine neoplasm syndrome

Design outcomes

Primary

MeasureTime frame
To determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism.One year

Secondary

MeasureTime frame
To determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism.One year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026