Status:
COMPLETED
Physiologic Regulation of FGF-23
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Hypoparathyroidism
Eligibility:
All Genders
18+ years
Brief Summary
This study will explore the regulation of fibroblast growth factor-23 (FGF-23). It is a hormone recently identified as a regulator of the blood levels of phosphorus and vitamin D, both of which are es...
Detailed Description
Vitamin D and phosphate are central to normal mineral homeostasis and important in many physiologic functions including skeletal integrity. For several decades parathyroid hormone (PTH) has been recog...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Adult hypoparathyroid patients, as defined by low or inappropriately normal PTH levels despite hypocalcemia, who are on a stable treatment regimen of calcitriol and calcium supplementation, and who are willing to participate in the study will be eligible.
- Adult PHP1B patients as defined by the clinical syndrome of elevated PTH and phosphorus and confirmed by methylation analysis of the GNAS gene.
- EXCLUSION CRITERIA
- Renal insufficiency as evidenced by a creatinine clearance of less than 50 ml/min
- Medically unstable patients
- Uncontrolled comorbid conditions, e.g., diabetes, coronary artery disease, congestive heart failure, or cerebrovascular disease.
- Digitalis therapy
- Patients on diuretic therapy, especially thiazides
- Pregnant and lactating women
- Patients whose hypoparathyroidism is caused by severe calcium-sensing receptor defects. These patients begin to have marked symptoms of "hypercalcemia" when the serum calcium is in the mid-normal range.
- Patients under 18 years of age
- Patients with history of any bone cancer, skeletal metastases or previous radiotherapy to the skeleton, unexplained elevations of serum alkaline phosphatase
Exclusion
Key Trial Info
Start Date :
July 19 2006
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00356512
Start Date
July 19 2006
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892