Coexisting Thyroid Disease and Hyperparathyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexander Stojadinovic, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01306916
First received: January 12, 2011
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

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
Hyperthyroidism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coexisting Thyroid Disease and Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • To determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2004
Study Completion Date: July 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1 of 1
diagnosis of primary and secondary hyperparathyroidism scheduled to undergo parathyroid resection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 12, 2011
Last Updated: July 2, 2012
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
thyroid disease, hyperthyroidism

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

ClinicalTrials.gov processed this record on April 21, 2014