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FGF-23 Suppressibility by Calcitonin

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00688077
Enrollment
49
Registered
2008-06-02
Start date
2008-05-31
Completion date
Unknown
Last updated
2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypophosphatemia

Keywords

Fibroblast growth factor - 23, Calcitonin

Brief summary

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.

Interventions

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

DRUGPlacebo

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

Sponsors

Rijnstate Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
20 Years to 55 Years
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.

Design outcomes

Primary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026