FGF-23 Suppressibility by Calcitonin

Hypophosphatemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688077
• Other study ID #: LTC-524/030408
• Status: Completed
• Phase: N/A
• First received: May 28, 2008
• Last updated: June 27, 2016
• Start date: May 2008

Study information

• Verified date: June 2016
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypophosphatemia

Intervention

Drug:
• Calcitonin
Calcitonin 200 IU/ml, single subcutaneous injection, experimental group
• Placebo
NaCl 0,9 % 1ml, single subcutaneous injection, placebo group

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.		eight hours	No