Coexisting Thyroid Disease and Hyperparathyroidism

Hyperthyroidism Clinical Trial

Official title:

Coexisting Thyroid Disease and Hyperparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306916
• Other study ID #: 04-20018
• Status: Completed
• Phase: N/A
• First received: January 12, 2011
• Last updated: July 2, 2012
• Start date: September 2004
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Walter Reed Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperthyroidism
• Thyroid Diseases

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism.		One year	No
Secondary	To determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism.		One year	No