FGF-23 Suppressibility by Calcitonin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rijnstate Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00688077
First received: May 28, 2008
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Hypophosphatemia
Drug: Calcitonin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: May 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688077

Contacts
Contact: Hans Boer de, MD, PhD 31-2-6378-8888 hdeboer@alysis.nl
Contact: Carmen Horjus, MD chthorje@alysis.nl

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands
Principal Investigator: Hans Boer de, MD, PhD         
Sponsors and Collaborators
Rijnstate Hospital
  More Information

No publications provided

Responsible Party: H. de Boer MD. PhD., Rijnstate Hospital, Arnhem
ClinicalTrials.gov Identifier: NCT00688077     History of Changes
Other Study ID Numbers: LTC-524/030408
Study First Received: May 28, 2008
Last Updated: August 8, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Rijnstate Hospital:
Fibroblast growth factor - 23
Calcitonin

Additional relevant MeSH terms:
Hypophosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014