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FGF-23 Suppressibility by Calcitonin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688077
First Posted: June 2, 2008
Last Update Posted: June 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rijnstate Hospital
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 ]

Enrollment: 49
Study Start Date: May 2008
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688077


Locations
Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
  More Information

Responsible Party: H. de Boer MD. PhD., Rijnstate Hospital, Arnhem
ClinicalTrials.gov Identifier: NCT00688077     History of Changes
Other Study ID Numbers: LTC-524/030408
First Submitted: May 28, 2008
First Posted: June 2, 2008
Last Update Posted: June 28, 2016
Last Verified: June 2016

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
Vasodilator Agents