FGF-23 Suppressibility by Calcitonin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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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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Detailed Description

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Conditions

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Hypophosphatemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

Calcitonin

Intervention Type DRUG

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

2

NaCl 0,9% 2 ml, single subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Calcitonin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes