FGF-23 Suppressibility by Calcitonin

June 27, 2016 updated by: Rijnstate Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: Calcitonin
Calcitonin 200 IU/ml, single subcutaneous injection, experimental group
PLACEBO_COMPARATOR: 2
NaCl 0,9% 2 ml, single subcutaneous injection
Drug: Placebo
NaCl 0,9 % 1ml, single subcutaneous injection, placebo group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (ESTIMATE)

June 2, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTC-524/030408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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