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Completed

NCT Number: NCT01306916

Coexisting Thyroid Disease and Hyperparathyroidism

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Reed Army Medical Center

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: One year

Secondary outcomes

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

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Walter Reed Army Medical Center

Fed

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2012
First posted
Mar 2, 2011
Registry last updated
Jul 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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