FGF-23 Suppressibility by Calcitonin

NCT00688077 — Not applicable, Completed, 49 participants, Rijnstate Hospital

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Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study

Registry	NCT00688077
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: single, basic science
Enrollment	49 (Actual)
Sponsor	Rijnstate Hospital (Other)
Conditions	Hypophosphatemia
Interventions	Calcitonin, Placebo (Drug)
Dates	start 2008-05-01, primary completion 2012-12-01, first posted 2008-06-02, last updated 2016-06-28
Locations	1 site in Netherlands

-Summary

Introduction:

Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans.

Aim:

In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.

Study Design:

placebo-controlled, cross-over study

Method:

* All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml NaCl 0.9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously
* On both occasions frequent bloodsampling will take place, out an indwelling catheter in de forearm vein.
* Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes
* Mealtimes: Calcium and Phosphate intake standardized on both occasions
* All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics, San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23
* Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca, albumin, PO4, PTH, 25-OHD and 1,25-OHD

Endpoint:

A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: Calcitonin
2	Placebo comparator	Drug: Placebo	NaCl 0,9% 2 ml, single subcutaneous injection

Calcitonin (Drug): Calcitonin 200 IU/ml, single subcutaneous injection, experimental group
Placebo (Drug): NaCl 0,9 % 1ml, single subcutaneous injection, placebo group

+Outcome measures

Primary outcomes

A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU. [eight hours]

+Eligibility

Sex: Male, ages: 20 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Healthy man, who are between 20-55 years old, and have a BMI 20-27 kg/m2.

Exclusion Criteria:

* Serum creatinin >100 mmol/L, or glomerular filtration rate <80 ml/min.
* Abnormal serum Ca, PO4, albumin, 25-OH vitamin D, or PTH levels.
* Any medication.

+Locations (1)

Facility	City	Country	Status
Rijnstate Hospital	Arnhem, Gelderland	Netherlands