Hypoparathyroidism Clinical Trial
Official title:
Physiologic Regulation of FGF-23
NCT number | NCT00356512 |
Other study ID # | 060188 |
Secondary ID | 06-D-0188 |
Status | Completed |
Phase | N/A |
First received | July 25, 2006 |
Last updated | June 30, 2017 |
Start date | July 19, 2006 |
Verified date | September 2, 2009 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 essential for overall health and especially important for bone health. The
parathyroid hormone (PTH) regulates phosphorus and calcium, but people with
hypoparathyroidism or pseudohypoparathyroidism do not have sufficient PTH action. There are
genetic diseases that influence FGF-23, causing abnormal metabolism of phosphorus and vitamin
D, thus affecting the bones. Also, there are rare tumors that may cause overproduction of
FGF-23 causing debilitating bone disease.
Patients ages 18 and older who have low PTH levels, or are resistant to PTH action, and take
calcitriol and calcium supplements, who are not pregnant, and who do not have kidney
disorders may be eligible for this study. During the 4-day study, patients will be provided
with a controlled diet that has a lower than usual phosphorus content. On day 1, patients
will be admitted to the NIH Clinic Center and undergo blood and urine tests to measure
calcium, phosphorus, vitamin D, and FGF-23. They will continue with their regular medicine
for hypoparathyroidism. On that day and throughout the study, patients will fast from 10:00
p.m. to 8:00 a.m. the following day. On day 2, patients will continue fasting until 4:00 p.m.
A tube will be placed in the vein of each arm: one for drawing blood and the other for
infusing calcium. Just one intravenous (IV) line will be used on the other days. Patients
will receive calcium chloride for 8 hours, at a dose carefully monitored by a machine. The
purpose is to bring the blood calcium level to the high normal range or just above. Blood and
urine samples will be collected periodically, to check for effects of calcium chloride on
FGF-23 and PTH. On days 3 and 4, patients will not take calcitriol and calcium but will
receive injections of PTH, under the skin, two times each day. On day 3, blood and urine
samples will be again be collected for analysis. On day 4, patients will receive one dose of
calcitriol by IV. The total amount of blood drawn during this study will be about 5 ounces.
Status | Completed |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | September 2, 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Jonsson KB, Zahradnik R, Larsson T, White KE, Sugimoto T, Imanishi Y, Yamamoto T, Hampson G, Koshiyama H, Ljunggren O, Oba K, Yang IM, Miyauchi A, Econs MJ, Lavigne J, Jüppner H. Fibroblast growth factor 23 in oncogenic osteomalacia and X-linked hypophosphatemia. N Engl J Med. 2003 Apr 24;348(17):1656-63. — View Citation
Kumar R. Phosphatonin--a new phosphaturetic hormone? (lessons from tumour-induced osteomalacia and X-linked hypophosphataemia). Nephrol Dial Transplant. 1997 Jan;12(1):11-3. Review. — View Citation
Yamazaki Y, Okazaki R, Shibata M, Hasegawa Y, Satoh K, Tajima T, Takeuchi Y, Fujita T, Nakahara K, Yamashita T, Fukumoto S. Increased circulatory level of biologically active full-length FGF-23 in patients with hypophosphatemic rickets/osteomalacia. J Clin Endocrinol Metab. 2002 Nov;87(11):4957-60. — View Citation
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