Status:
COMPLETED
Cinacalcet to Treat Familial Primary Hyperparathyroidism
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hypercalcemia
Familial Primary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 p...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Criteria for inclusion
- Patients with primary hyperparathyroidism associated with MEN1 or 2A syndrome and no indications for current surgical interventions.
- For initial pilot study, 15-20 patients with MEN1 syndrome and biochemical evidence of hyperparathyroidism will be included.
- 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.
- In case of ZES, good acidity control with proton pump inhibitors (PPI), documented by basal acid output (BAO) of less than 10 mEq/h.
- Willingness and legal ability to give informed consent.
- 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
- Age less than 18 years
- Pregnancy
- Creatinine greater than 1.4
- SGOT or SGPT greater than twice normal
- Indications for current surgery:
- 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
- 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
- Chemotherapy within last 6 months
- Lactating females
- Patients with contraindications for MRI study, including pacemakers, vascular clips, implants, foreign bodies etc., as per NIH-MRI Safety Guideline.
Exclusion
Key Trial Info
Start Date :
May 9 2006
Trial Type :
INTERVENTIONAL
End Date :
March 31 2007
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00325104
Start Date
May 9 2006
End Date
March 31 2007
Last Update
July 2 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892