FGF-23 Suppressibility by Calcitonin

Not Applicable

Completed

• Conditions: Hypophosphatemia
• Interventions: Drug: Placebo; Drug: Calcitonin

• Registration Number: NCT00688077
• Lead Sponsor: Rijnstate Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-02
• Primary Completion: 2012-12
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	NaCl 0,9% 2 ml, single subcutaneous injection
1	Calcitonin	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands