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FGF-23 Suppressibility by Calcitonin

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. Identifier: NCT00688077
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : June 28, 2016
Information provided by:
Rijnstate Hospital

Brief Summary:


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.


In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.

Study Design:

placebo-controlled, cross-over study


  • 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


A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.

Condition or disease Intervention/treatment Phase
Hypophosphatemia Drug: Calcitonin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00688077

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Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
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Responsible Party: H. de Boer MD. PhD., Rijnstate Hospital, Arnhem Identifier: NCT00688077    
Other Study ID Numbers: LTC-524/030408
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Keywords provided by Rijnstate Hospital:
Fibroblast growth factor - 23
Additional relevant MeSH terms:
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Phosphorus Metabolism Disorders
Metabolic Diseases
Salmon calcitonin
Calcitonin Gene-Related Peptide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents