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Cinacalcet Actions in Familial Primary Hyperparathyroidism

Phase 3
18 Years
Not Enrolling
Hypercalcemia, Familial Primary Hyperparathyroidism

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Trial Information

Cinacalcet Actions in Familial Primary Hyperparathyroidism

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.

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

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.


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.

Type of Study:


Study Design:

Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

May 2006

Completion Date:

March 2007

Related Keywords:

  • Hypercalcemia
  • Familial Primary Hyperparathyroidism
  • Multiple Endocrine Neoplasia
  • Gastrinoma
  • Prolacinoma
  • Medullary Thyroid Cancer
  • Insulinoma
  • MEN1
  • MEN2A
  • Familial Primary Hyperparathytoidism
  • Hypercalcemia
  • Hyperparathyroidism
  • Hyperparathyroidism, Primary



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892