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Coexisting Thyroid Disease and Hyperparathyroidism

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ClinicalTrials.gov Identifier: NCT01306916
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : July 3, 2012
Sponsor:
Information provided by (Responsible Party):
Alexander Stojadinovic, Walter Reed National Military Medical Center

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).


Condition or disease
Hyperthyroidism

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coexisting Thyroid Disease and Hyperparathyroidism
Study Start Date : September 2004
Actual Primary Completion Date : December 2010
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Group/Cohort
Group 1 of 1
diagnosis of primary and secondary hyperparathyroidism scheduled to undergo parathyroid resection.



Primary Outcome Measures :
  1. To determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. To determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism. [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306916


Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center

Responsible Party: Alexander Stojadinovic, Director, Combat Wound Initiative Program, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01306916     History of Changes
Other Study ID Numbers: 04-20018
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: July 2012

Keywords provided by Alexander Stojadinovic, Walter Reed National Military Medical Center:
thyroid disease, hyperthyroidism

Additional relevant MeSH terms:
Hyperparathyroidism
Thyroid Diseases
Hyperthyroidism
Parathyroid Diseases
Endocrine System Diseases