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Cinacalcet to Treat Familial Primary Hyperparathyroidism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00325104
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date  ICMJE May 11, 2006
First Posted Date  ICMJE May 12, 2006
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE May 9, 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cinacalcet to Treat Familial Primary Hyperparathyroidism
Official Title  ICMJE Cinacalcet Actions in Familial Primary Hyperparathyroidism
Brief Summary

This study will evaluate the benefits and side effects of a new medication called Cinacalcet for treating patients with primary hyperparathyroidism associated with multiple endocrine neoplasia type 1 (MEN1) or type 2A (MEN2A). Patients with primary hyperparathyroidism have elevated levels of blood calcium caused by too much parathyroid hormone released by one or more parathyroid tumors. The parathyroids are small glands located in the neck. Most cases of primary hyperparathyroidism are due to a single overactive parathyroid gland, but in MEN1 and MEN2A, several glands are overgrown and overactive. Cinacalcet decreases the secretion of parathyroid hormone.

Patients 18 years of age and older with primary hyperparathyroidism and MEN1 or MEN2A and who are not candidates for parathyroid surgery may be eligible for this study.

Participants are admitted to the Clinical Center for 1 week blood and urine tests and imaging studies, and initiation of Cinacalcet treatment. They take the drug by mouth and have daily blood tests until the dosage required to achieve normal blood calcium levels is determined. Patients return to the hospital 2 weeks later for 1 week to evaluate the response to the drug and make any necessary adjustments. Treatment may continue for as long as 1 year with 1-week admissions every 3 months to monitor the benefits and side effects of Cinacalcet. Evaluations may include the following:

  • Blood and urine analyses.
  • Measurement of gastric acid secretion. For this test, a soft plastic tube is inserted into the nose or mouth and then swallowed and then gently removed about an hour later.
  • Injections of secretin, calcium and arginine into a vein and collection of blood samples to measure the responding increase in levels of gastrin, calcitonin and insulin, respectively. These tests are used to diagnose and monitor hormone secretion from endocrine tumors and are used in this study to assess the response to Cinacalcet treatment.
  • Radioisotope test to evaluate tumors of the endocrine organs. A radioactive substance injected into a vein is taken up by the endocrine tissue and the concentrated radioactivity is measured.
  • Imaging tests, such as MRI and CT, to detect or follow growing tumors in the pituitary, neck, and abdomen. CT is a special type of x-ray machine that visualizes tissues, such as thyroid or parathyroid tumors. MRI uses a magnetic field and radio waves to obtain pictures of different tissues in the head, neck and abdomen.
  • DEXA scan to assess bone density. This test uses standard low-intensity x-rays.
Detailed Description This study will evaluate safety and efficacy of short- and long-term Cinacalcet in treatment of hypercalcemia of familial primary hyperparathyroidism. The study population will include patients with primary hyperparathyroidism caused by multiple endocrine neoplasia type 1 or type 2A. This is a prospective unblinded pilot study, where each patient will serve as his/her own control. It will include 6 one-week-long admissions, over a 1 year period. Main measurements will be tests of hyperparathyroidism such as parathyroid hormone and serum calcium as well as tests of nonparathyroid tumors. The latter tests may include hormones released by the tumors and images of the tumors.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Hypercalcemia
  • Familial Primary Hyperparathyroidism
Intervention  ICMJE
  • Procedure: Parathyroid hormone testing
  • Procedure: Serum calcium testing
Study Arms  ICMJE Not Provided
Publications * Rizzoli R, Green J 3rd, Marx SJ. Primary hyperparathyroidism in familial multiple endocrine neoplasia type I. Long-term follow-up of serum calcium levels after parathyroidectomy. Am J Med. 1985 Mar;78(3):467-74.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 11, 2006)
25
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 31, 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:

Criteria for inclusion

  1. Patients with primary hyperparathyroidism associated with MEN1 or 2A syndrome and no indications for current surgical interventions.
  2. For initial pilot study, 15-20 patients with MEN1 syndrome and biochemical evidence of hyperparathyroidism will be included.
  3. For initial pilot study, 5-10 patients with MEN2A syndrome and biochemical evidence of hyperparathyroidism will be included. Each MEN2A case must have residual MTC tumor.
  4. In case of ZES, good acidity control with proton pump inhibitors (PPI), documented by basal acid output (BAO) of less than 10 mEq/h.
  5. Willingness and legal ability to give informed consent.
  6. MEN1, like MEN2A has a normal gender and ethnic distribution. These will be maintained, within the limits of a small number of subjects studied.

EXCLUSION CRITERIA:

Criteria for exclusion or removal

  1. Age less than 18 years
  2. Pregnancy
  3. Creatinine greater than 1.4
  4. SGOT or SGPT greater than twice normal
  5. Indications for current surgery:

    1. Hyperparathyroidism

      • Albumin-adjusted serum calcium level higher than 3.0 mmol/L (12.0 mg/dL)
      • Kidney stones
      • Significant PTH-induced bone disease
      • Age below 50 is not considered as absolute indication for parathyroid surgery herein
    2. Enteropancreatic neuroendocrine neoplasia

      • Single lesion meeting criteria for surgery
      • Need for debulking surgery for obstructive or other complications
      • Acute abdominal complications of any kind
      • Inability of control on PPI in case of ZES
  6. Chemotherapy within last 6 months
  7. Lactating females
  8. Patients with contraindications for MRI study, including pacemakers, vascular clips, implants, foreign bodies etc., as per NIH-MRI Safety Guideline.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00325104
Other Study ID Numbers  ICMJE 060163
06-DK-0163
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 31, 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP