FGF-23 Suppressibility by Calcitonin

NCT00688077 | Completed

• 1 other identifier: LTC-524/030408
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypophosphatemia

Keywords

Fibroblast growth factor - 23; Calcitonin

Outcome Measures

Primary Outcomes (1)

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

  eight hours

Study Arms (2)

1

EXPERIMENTAL

Drug: Calcitonin

2

PLACEBO COMPARATOR

NaCl 0,9% 2 ml, single subcutaneous injection

Drug: Placebo

Interventions

Calcitonin DRUG

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

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy man, who are between 20-55 years old, and have a BMI 20-27 kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Location

MeSH Terms

Conditions

Hypophosphatemia

Interventions

Calcitonin

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroid Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

NL (1)