In this studie we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
fysiologische regulatie fosfaat houshouding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A significant change in de serum FGF-23 levels in response to a single
subcutaneous injection of calcitonin 200 IU.
Secondary outcome
De serum levels for calcium, parathormon and vitamin D.
Background summary
Fibroblast growth factor 23 (FGF-23) is a recently discovered hormone that
inhibits renal tubular phosphate absorption and 1-alfa hydroxylation of vitamin
D. Next to PTH it probably is the most important hormone to maintain phosphate
homeostasis in man. The source of FGF-23 is not exactly known, however several
data sugest that it is secreted by osteogenic cells in response to
hyperphosphatemia. FGF-23 serum levels change in response to dietary phosphate
loading and restriction. A negative hormonal feedback signal for FGF-23
production has not been discovered yet.
We recently discovered that calcitonin markedly suppressed FGF-23 production in
a patient with tumor-induced osteomalacia caused by an FGF-23 secreting
leiomyoma. Calcitonin is produced by the parafollicular cells of the thyroid
gland. It has been shown to lower serum calcium and phosphate, primarily by
inhibiting osteoclast-mediated bone resorption. Its exact physiological remains
still unclear.
Based on our experience with calcitonin as an FGF-23 suppressive agent, we
hypothesize that calcitonin may be a physiologically important regulator of
FGF-23 production and secretion in healthy humans. The reported serum half life
of FGF-23 varies between 21 and 57 minutes, threfore if calcitonin should have
significant suppressive effects it must be detectable within a period of 8
hours.
Study objective
In this studie we wish to examine the FGF-23 suppressive effects of calcitonin
in healthy men.
Study design
Double blind, placebo controlled, cross-over study.
Intervention
All subjects are examined on two occasions, once after exposure to placebo 1 ml
NaCl 0.9% subcutaneously, and once following 1 ml calcitonin 200 IU/ml
subcutaneously.
Study burden and risks
The burden associated with participation to the study lies mostly in the fact
that the persons have to spend some time in the hospital, in total
approximately 18 hours, because of the frequent bloedsampling. Furthermore the
subjects will be asked to use a standard phosphate enriched diet for four days
before and on the intervention day.
An allergic reaction due to subcutaneous administration of calcitonin could
also be considered as a minor risk.
Wagnerlaan 55
6800 TA, Arnhem
Nederland
Wagnerlaan 55
6800 TA, Arnhem
Nederland
Listed location countries
Age
Inclusion criteria
Healthy, male sex, age 20-55 years
Exclusion criteria
Serum creatinin > 100 micromol/L, or glomerular filtration rate < 80 ml/min;
Abnormal serum calcium, phosphate, albumin, vitamin D, or PTH level;
Any medication;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21603.091.08 |