NCT00688077

FGF-23 Suppressibility by Calcitonin

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypophosphatemia

Interventions

Type	Name	Description
DRUG	Calcitonin	Calcitonin 200 IU/ml, single subcutaneous injection, experimental group
DRUG	Placebo	NaCl 0,9 % 1ml, single subcutaneous injection, placebo group

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-12-01
• First posted: 2008-06-02
• Last updated: 2016-06-28

Locations

1 site across 1 country: Netherlands