Coexisting Thyroid Disease and Hyperparathyroidism

NCT01306916 | Completed

• 1 other identifier: 04-20018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Hyperthyroidism

Keywords

thyroid disease, hyperthyroidism

Outcome Measures

Primary Outcomes (1)

• To determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism.

  One year

Secondary Outcomes (1)

• To determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism.

  One year

Study Arms (1)

Group 1 of 1

diagnosis of primary and secondary hyperparathyroidism scheduled to undergo parathyroid resection.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 military health care beneficiaries over the age of 18 years with primary and secondary hyperparathyroidism scheduled to undergo parathyroid resection.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Hyperthyroidism; Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Combat Wound Initiative Program

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: March 2, 2011
• Study Start: September 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2012
• Last Updated: July 3, 2012

Record last verified: 2012-07

Locations

US (1)