FGF-23 Suppressibility by Calcitonin

• Sponsor: Rijnstate Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00688077
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypophosphatemia	Drug: Calcitonin; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• 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 1, 2008
• Actual Primary Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

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. [eight hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate Hospital	Arnhem	Gelderland	Netherlands

Sponsors and Collaborators

• Rijnstate Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00688077
• Other Study ID Numbers: LTC-524/030408
• First Posted: Jun 2, 2008
• Last Update Posted: Jun 28, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by , ,: Fibroblast growth factor - 23; Calcitonin
• Additional relevant MeSH terms: Hypophosphatemia; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin

Study Results

No Results Posted as of Jun 28, 2016