Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325104
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-05-11
Brief Title:
Cinacalcet to Treat Familial Primary Hyperparathyroidism
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cinacalcet Actions in Familial Primary Hyperparathyroidism
Status:
COMPLETED
Status Verified Date:
2007-03-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 hisher 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-DK-0163 | None | None | None |