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FGF-23 Suppressibility by Calcitonin

NCT00688077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2016-06-28

No results posted yet for this study

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

DRUG

Calcitonin

Calcitonin 200 IU/ml, single subcutaneous injection, experimental group

DRUG

Placebo

NaCl 0,9 % 1ml, single subcutaneous injection, placebo group

Sponsors & Collaborators

  • Rijnstate Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-12-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00688077 on ClinicalTrials.gov